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Trial registered on ANZCTR


Registration number
ACTRN12625000184471
Ethics application status
Approved
Date submitted
8/11/2024
Date registered
17/02/2025
Date last updated
17/02/2025
Date data sharing statement initially provided
17/02/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the Effects of Propofol-Dexmedetomidine and Propofol-Remifentanil Combinations on the Success of Classical LMA (Laryngeal Mask Airway) Placement, Haemodynamic Response and Pharyngolaryngeal Morbidity in ASA I-II Patients
Scientific title
Comparison of the Effects of Propofol-Dexmedetomidine and Propofol-Remifentanil Combinations on the Success of Classical LMA (Laryngeal Mask Airway) Placement, Haemodynamic Response and Pharyngolaryngeal Morbidity in ASA I-II Patients Undergoing Elective Surgery
Secondary ID [1] 313319 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anesthesiology 335692 0
Airway management 335693 0
Condition category
Condition code
Anaesthesiology 332256 332256 0 0
Anaesthetics
Anaesthesiology 332257 332257 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Description:Group D (Dexmedetomidine Group)

This study was completed after receiving permission from Okmeydani Education and Research and Firat University Faculty of Medicine Drug Research Local Ethics Committee (date 5/11/2013 and decision number 134) and with informed consent from patients. The study included 80 patients classified as ASA I-II according to the ASA physiological classification, aged 18-65 years, undergoing elective surgery without requiring muscle relaxants, with operation duration not exceeding 2 hours and with indications for LMA insertion. Cases with any neck and upper respiratory tract pathology, history or possibility of difficult airway (Mallampati class 3-4, sternomental distance less than 12 cm, thyromental distance less than 6 cm, head extension less than 90 degrees, mouth opening less than 1.5 cm), morbid obesity, history of pulmonary disease, history of allergy to the study drugs, history of alcohol and substance dependence, history of chronic sedative and opioid analgesic use, throat pain, dysphagia, and dysphonia were excluded from the study.

Group D (Dexmedetomidine Group)

- Drug Administered: Patients in Group D received 1 µg/kg dexmedetomidine. Test syringes contained 20 mL of dexmedetomidine solution, diluted with 0.9% saline to a total of 50 mL. An independent anaesthesia expert prepared these syringes.

- Monitoring: Anaesthesia depth was monitored using the BIS-Vista™ system (Aspect Medical Systems; Newton, MA, USA).

- Blinding: The anaesthesiologist responsible for LMA insertion and monitoring parameters was blinded to the administered drug.

Before anaesthesia, patients were taken to the operating room, where standard monitoring was performed, including heart rate (HR), systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), electrocardiography (ECG; lead II), and peripheral oxygen saturation (SpO2). Patients had venous access in the back of the hand with a 20 G cannula and were administered 7 mL/kg saline infusion before induction. Patients in Group D were given 1 µg/kg dexmedetomidine in a 50 mL injector completed to 50 mL with 0.9% NaCl (Precedex®, 100 µg/mL, Hospira, USA), infused over 10 minutes with an infusion pump (Braun Infusomat®; Braun Melsungen Ko, Germany). Thirty seconds after the dexmedetomidine infusion, 2.5 mg/kg propofol was administered over 30 seconds for anaesthesia induction.

During the perioperative period, if hypotension occurred (defined as a reduction in MAP of >30% compared to baseline values), 6 mg ephedrine (Efedrin, Haver, Istanbul, Türkiye) was administered. Bradycardia, defined as HR less than 50 beats/min, was treated with 0.5 mg IV atropine (atropine sulphate, Haver, Istanbul, Türkiye). With eyelash reflex checks after induction, patients were ventilated with 100% O2 using a face mask. The time from the start of induction agent administration until the loss of the eyelash reflex was recorded.

Ninety seconds after propofol administration, when BIS values were below 40 and sufficient chin relaxation was achieved, the LMA size was selected according to the patient’s body weight, as recommended in the manufacturer’s guidelines. The LMA was lubricated with a water-soluble gel on the side facing the oropharynx, the cuffs were fully deflated, and it was inserted using the standard method described by Brain by a single researcher with more than 3 years of experience. After insertion, cuff pressure monitoring (cuff pressure manometer, Rüsch, Germany) was performed to standardize postoperative pharyngeal morbidity. The laryngeal mask cuff was inflated until the cuff pressure reached 60 cmH2O, which was maintained throughout the operation.

The duration until successful insertion (time from mouth opening to first successful ventilation) was recorded. Criteria for successful insertion included observing square waveforms on the capnogram, easy ventilation with a respiratory balloon, visible chest movements, and no air leak with 20 cmH2O positive pressure ventilation. Anaesthesia maintenance ensured BIS values between 40 and 60 and was achieved using 1.5-2% sevoflurane in a 40% O2/60% N2O mixture. If sufficient induction was not achieved, and no movement was observed during the first attempt, an additional dose of 1 mg/kg propofol was administered to keep BIS values below 40, and a second LMA insertion attempt was made. The number of attempts was recorded, but insertion conditions were assessed only during the first attempt.

Postoperative Monitoring

SAP, DAP, MAP, HR, BIS, and SpO2 values were recorded at baseline, immediately before LMA insertion, and at the 1st, 2nd, 3rd, 4th, and 5th minutes after insertion. Apnoea duration (the time from the last spontaneous respiration before induction to the first spontaneous respiration) was recorded. Five minutes before the end of the operation, 100% O2 was administered. Before removing the LMA, intracuff pressure was measured again and recorded. In the presence of sufficient ventilation, the LMA was removed, and the duration of LMA use (time between insertion and removal) was recorded. After removing the laryngeal mask, the presence of blood was assessed on a scale: 1 (no blood seen), 2 (trace amounts), and 3 (significant amount of blood).

Postoperative Complications

Waking patients were sent to the recovery unit with 100% oxygen. To determine the frequency and severity of pharyngolaryngeal complications, a single researcher, blind to group assignment and not involved in the anaesthesia process, evaluated all patients upon discharge from the recovery unit and again 24 hours later for throat pain (constant pain, independent of swallowing) and dysphagia (difficulty swallowing, provoked by drinking). Patients were asked about the presence or absence of these symptoms. Throat pain was assessed as follows:
- 0 points: No complaint,
- 1 point: Mild throat pain,
- 2 points: Moderate throat pain,
- 3 points: Severe throat pain.
Intervention code [1] 329919 0
Treatment: Drugs
Comparator / control treatment
Comparator/control treatment is Group R (Remifentanil Group)

•Drug Administered: Patients in Group R received 2 µg/kg remifentanil. Test syringes contained 20 mL of remifentanil solution, diluted with 0.9% saline to a total of 50 mL. An independent anaesthesia expert prepared these syringes.
•Monitoring: Anaesthesia depth was monitored using the BIS-Vista™ system (Aspect Medical Systems; Newton, MA, USA).
•Blinding: The anaesthesiologist responsible for LMA insertion and monitoring parameters was blinded to the administered drug.

Before anaesthesia, patients were taken to the operating room, where standard monitoring was performed, including heart rate (HR), systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), electrocardiography (ECG; lead II), and peripheral oxygen saturation (SpO2). Patients had venous access in the back of the hand with a 20 G cannula and were administered 7 mL/kg saline infusion before induction. Patients in Group R were given 2 µg/kg remifentanil in a 50 mL injector completed to 50 mL with 0.9% NaCl, infused over 60 seconds with an infusion pump (Braun Infusomat®; Braun Melsungen Ko, Germany). Thirty seconds after the remifentanil infusion, 2.5 mg/kg propofol was administered over 30 seconds for anaesthesia induction.
During the perioperative period, if hypotension occurred (defined as a reduction in MAP of >30% compared to baseline values), 6 mg ephedrine (Efedrin, Haver, Istanbul, Türkiye) was administered. Bradycardia, defined as HR less than 50 beats/min, was treated with 0.5 mg IV atropine (atropine sulphate, Haver, Istanbul, Türkiye). With eyelash reflex checks after induction, patients were ventilated with 100% O2 using a face mask. The time from the start of induction agent administration until the loss of the eyelash reflex was recorded.
Ninety seconds after propofol administration, when BIS values were below 40 and sufficient chin relaxation was achieved, the LMA size was selected according to the patient’s body weight, as recommended in the manufacturer’s guidelines. The LMA was lubricated with a water-soluble gel on the side facing the oropharynx, the cuffs were fully deflated, and it was inserted using the standard method described by Brain by a single researcher with more than 3 years of experience. After insertion, cuff pressure monitoring (cuff pressure manometer, Rüsch, Germany) was performed to standardize postoperative pharyngeal morbidity. The laryngeal mask cuff was inflated until the cuff pressure reached 60 cmH2O, which was maintained throughout the operation.
The duration until successful insertion (time from mouth opening to first successful ventilation) was recorded. Criteria for successful insertion included observing square waveforms on the capnogram, easy ventilation with a respiratory balloon, visible chest movements, and no air leak with 20 cmH2O positive pressure ventilation. Anaesthesia maintenance ensured BIS values between 40 and 60 and was achieved using 1.5-2% sevoflurane in a 40% O2/60% N2O mixture. If sufficient induction was not achieved, and no movement was observed during the first attempt, an additional dose of 1 mg/kg propofol was administered to keep BIS values below 40, and a second LMA insertion attempt was made. The number of attempts was recorded, but insertion conditions were assessed only during the first attempt.
Postoperative Monitoring
SAP, DAP, MAP, HR, BIS, and SpO2 values were recorded at baseline, immediately before LMA insertion, and at the 1st, 2nd, 3rd, 4th, and 5th minutes after insertion. Apnoea duration (the time from the last spontaneous respiration before induction to the first spontaneous respiration) was recorded. Five minutes before the end of the operation, 100% O2 was administered. Before removing the LMA, intracuff pressure was measured again and recorded. In the presence of sufficient ventilation, the LMA was removed, and the duration of LMA use (time between insertion and removal) was recorded. After removing the laryngeal mask, the presence of blood was assessed on a scale: 1 (no blood seen), 2 (trace amounts), and 3 (significant amount of blood).
Postoperative Complications
Waking patients were sent to the recovery unit with 100% oxygen. To determine the frequency and severity of pharyngolaryngeal complications, a single researcher, blind to group assignment and not involved in the anaesthesia process, evaluated all patients upon discharge from the recovery unit and again 24 hours later for throat pain (constant pain, independent of swallowing) and dysphagia (difficulty swallowing, provoked by drinking). Patients were asked about the presence or absence of these symptoms. Throat pain was assessed as follows:
• 0 points: No complaint,
• 1 point: Mild throat pain,
• 2 points: Moderate throat pain,
• 3 points: Severe throat pain.
Control group
Active

Outcomes
Primary outcome [1] 339828 0
Compare the effects of propofol with remifentanil and propofol with dexmedetomidine on LMA insertion conditions.
Timepoint [1] 339828 0
LMA insertion conditions were evaluated during the first attempt immediately following the insertion of the LMA, approximately 90 seconds after propofol administration, when BIS values were below 40 and sufficient chin relaxation was achieved.
Primary outcome [2] 339829 0
In this study, all hemodynamic parameters, including Mean Arterial Pressure (MAP), Systolic Arterial Pressure (SAP), Diastolic Arterial Pressure (DAP), and Heart Rate (HR), were assessed as a composite outcome to provide an overall evaluation of the hemodynamic response during and after LMA insertion. Data for each parameter will be recorded at baseline, immediately before LMA insertion, and at the 1st, 2nd, 3rd, 4th, and 5th minutes after insertion.
Timepoint [2] 339829 0
Mean arterial pressure (MAP), systolic arterial pressure (SAP), diastolic arterial pressure (DAP), and heart rate (HR) were recorded at specific timepoints relevant to the outcome: baseline (before anaesthesia induction), 1 minute before LMA insertion, and at 1, 2, 3, 4, and 5 minutes after LMA insertion
Secondary outcome [1] 441553 0
Pharyngolaryngeal morbidity was assessed as a composite outcome that included the evaluation of the following components: presence of blood, throat pain, and dysphagia.
Timepoint [1] 441553 0
- The timepoints for assessing Pharyngolaryngeal Morbidity as described are: Immediately after LMA removal: Visual assessment for the presence of blood on the LMA. -Patients were assessed for throat pain (constant pain, independent of swallowing) and dysphagia (difficulty swallowing provoked by drinking) only upon discharge from the recovery unit. These assessments were performed by a single researcher blinded to group assignments and not involved in the anaesthesia process.

Eligibility
Key inclusion criteria
The study included 80 patients in group I-II according to the ASA physiological classification, age 18-65 years, undergoing elective surgery, without requiring muscle relaxants, with operation duration not over 2 hours and with indications for LMA insertion
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cases with any neck and upper respiratory tract pathology, history or possibility of difficult airway (Mallampati class 3-4, sternomental distance less than 12 cm, thyromental distance less than 6 cm, head extension less than 90 degrees, mouth opening less than 1.5 cm), with morbid obesity, history of pulmonary disease, history of allergy to the study drugs, history of alcohol and substance dependence, history of chronic sedative and opioid analgesic use, throat pain, dysphagia and dysphonia were not included in the study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation procedure such as coin-tossing will be used
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data were evaluated using IBM SPSS Statistics 26.0 (IBM Corp., Armonk, New York, USA) statistical package program. Descriptive statistics were presented with n, % for categorical variables, and the normality assumption of the data for continuous variables was examined with Mean, Standard Deviation or Median, Interquartile Range (IQR) values.Shapiro Wilk test was used to examine the distribution assumptions of continuous variables according to groups.The homogeneity of variances of continuous variables according to groups was evaluated with Levene Test.Independent sample t test or Mann Whitney U test was used to evaluate the means or distributions of two independent groups of continuous measurements. Pearson chi-square test, Fisher Exact, Continuity Correction Yates test was used to examine the relationship between categorical variables.Variance analysis was used in repeated measurements in the evaluation of heart rate and hemodynamic data according to D and R groups at 5 different times before, during and after baseline. Bonferroni multiple comparison test was used for comparisons between times.p<0.05 was considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2014
Date of last participant enrolment
Anticipated
Actual
1/07/2014
Date of last data collection
Anticipated
Actual
1/07/2014
Sample size
Target
81
Accrual to date
Final
74
Recruitment outside Australia
Country [1] 26709 0
Turkey
State/province [1] 26709 0

Funding & Sponsors
Funding source category [1] 317769 0
Hospital
Name [1] 317769 0
Okmeydani Education and Research Hospital
Country [1] 317769 0
Turkey
Primary sponsor type
University
Name
Firat University School of Medicine Hospital
Address
Country
Turkey
Secondary sponsor category [1] 320086 0
None
Name [1] 320086 0
Address [1] 320086 0
Country [1] 320086 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316457 0
Okmeydani Education and Research Hospital of Medicine Drug Research Local Ethics Committee
Ethics committee address [1] 316457 0
Ethics committee country [1] 316457 0
Turkey
Date submitted for ethics approval [1] 316457 0
24/10/2013
Approval date [1] 316457 0
05/11/2013
Ethics approval number [1] 316457 0
134-5/11/2013

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137946 0
A/Prof MENSURE ÇAKIRGÖZ
Address 137946 0
Güney Neighborhood, 1140/1 Street, No: 1, Yenisehir, Konak, Izmir, 35120, Turkey
Country 137946 0
Turkey
Phone 137946 0
+905066906977
Fax 137946 0
Email 137946 0
drmensure@gmail.com
Contact person for public queries
Name 137947 0
MENSURE ÇAKIRGÖZ
Address 137947 0
Güney Neighborhood, 1140/1 Street, No: 1, Yenisehir, Konak, Izmir, 35120, Turkey
Country 137947 0
Turkey
Phone 137947 0
+905066906977
Fax 137947 0
Email 137947 0
drmensure@gmail.com
Contact person for scientific queries
Name 137948 0
MENSURE ÇAKIRGÖZ
Address 137948 0
Güney Neighborhood, 1140/1 Street, No: 1, Yenisehir, Konak, Izmir, 35120, Turkey
Country 137948 0
Turkey
Phone 137948 0
+905066906977
Fax 137948 0
Email 137948 0
drmensure@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24321Ethical approval    388722-(Uploaded-08-11-2024-14-43-47)-CamScanner 15.09.2024 16.07.pdf



Results publications and other study-related documents

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