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Trial registered on ANZCTR


Registration number
ACTRN12625000275460
Ethics application status
Approved
Date submitted
8/11/2024
Date registered
10/04/2025
Date last updated
10/04/2025
Date data sharing statement initially provided
10/04/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the Effects of Propofol-Remifentanil and Thiopental-Remifentanil Administration on the Success of Classic Laryngeal Mask Airway (LMA) Placement, Hemodynamic Response, and Pharyngolaryngeal Morbidity: A Prospective Randomized Study
Scientific title
Comparison Of The Effects Of Propofol-Remifentanil And Thiopental-Remifentanil Administration On The Success Of Classic LMA Placement Hemodynamic Response And Pharyngolaryngeal Morbidity in ASA I-II Patients Undergoing Elective Surgery: A Prospective Randomized Study
Secondary ID [1] 313316 0
Nill known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anesthesiology 335670 0
Airway management 335671 0
Condition category
Condition code
Anaesthesiology 332230 332230 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Protocol and Methods:

This study was conducted after receiving approval from the Okmeydani Education and Research Hospital and Firat University Faculty of Medicine Drug Research Local Ethics Committee (decision number: 132). Informed consent was obtained from all participants. The study enrolled 80 patients classified as ASA I-II, aged 18–65 years, undergoing elective surgeries that did not require muscle relaxants, with a maximum duration of 2 hours and indications for laryngeal mask airway (LMA) insertion. Exclusion criteria included patients with neck or upper respiratory tract pathologies, a history or likelihood of difficult airway (Mallampati Class 3-4, sternomental distance <12 cm, thyromental distance <6 cm, head extension <90°, or mouth opening <1.5 cm), morbid obesity, history of pulmonary disease, allergies to study drugs, substance dependence, chronic sedative or opioid use, throat pain, dysphagia, or dysphonia.

Monitoring and Randomization:
Standard monitoring was conducted, including heart rate (HR), systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), electrocardiography (ECG), and peripheral oxygen saturation (SpO2). Depth of anesthesia was assessed using a BIS monitor (BIS-Vista™). Patients were randomized into two groups:

Group P (Control Group): 2 µg/kg remifentanil followed by 2.5 mg/kg propofol.
Group T (Thiopental Group): 2 µg/kg remifentanil followed by 5 mg/kg thiopental.
Anesthetic Procedure:
Preoxygenation was performed with 6 L/min oxygen for three minutes. Premedication included 0.03 mg/kg IV midazolam. Remifentanil (2 µg/kg) was infused over 60 seconds using an infusion pump. Propofol or thiopental was administered 30 seconds later over 30 seconds. The sequence was double-blinded; syringes were prepared by a nurse, and drug administration and LMA insertion were carried out by different personnel.

Eyelash reflex was monitored to confirm loss of consciousness. Ninety seconds after thiopental administration, patients with BIS values <40 and sufficient jaw relaxation underwent LMA insertion. The LMA size was determined based on patient weight and inserted using a standardized technique. Cuff pressure was maintained at 60 cmH2O.

Data Collection:
The duration to loss of eyelash reflex and time to successful LMA insertion (from mouth opening to the first effective ventilation) were recorded. LMA insertion conditions were assessed using a 6-variable scale: mouth opening, ease of insertion, swallowing, coughing/gagging, laryngospasm, and movement. Conditions were rated as:

Perfect: All variables rated as perfect.
Good: A mix of moderate and perfect ratings.
Poor: At least one variable rated as poor.
Hemodynamic parameters (SAP, DAP, MAP, HR, SpO2) were recorded at baseline, 1 minute before LMA insertion, and 1, 2, 3, 4, and 5 minutes after insertion. Apnea duration was recorded from the last spontaneous breath after induction to the first spontaneous breath.

Postoperative Evaluation:
LMA removal was conducted under 100% oxygen, and cuff pressure was recorded. The presence of blood on the LMA was categorized as none, trace amounts, or significant. Patients were monitored for throat pain (0 = none, 1 = mild, 2 = moderate, 3 = severe) and dysphagia (present/absent) by a blinded researcher. Hypotension (MAP reduction >30%) was treated with 6 mg ephedrine, and bradycardia (HR <50 bpm) with 0.5 mg atropine.
Intervention code [1] 329892 0
Treatment: Drugs
Comparator / control treatment
The control group in this study is Group P, which received 2 µg/kg remifentanil followed by 2.5 mg/kg propofol.
Control group
Active

Outcomes
Primary outcome [1] 339809 0
Compare the effects of the administration of thiopental or propofol with 2 µg.kg -1 remifentanil before induction on LMA insertion conditions and success.
Timepoint [1] 339809 0
Ninety seconds after thiopental or propofol administration when BIS values were under 40 and sufficient chin relaxation was provided.
Primary outcome [2] 339813 0
The results from all hemodynamic parameters (MAP, SAP, DAP, HR) will be assessed as a composite outcome.
Timepoint [2] 339813 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] 441456 0
Presence of Blood on the laryngeal mask airway
Timepoint [1] 441456 0
The presence of blood was assessed immediately after removing the laryngeal mask (LMA).
Secondary outcome [2] 444049 0
Throat Pain
Timepoint [2] 444049 0
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.
Secondary outcome [3] 444054 0
Dysphagia (difficulty swallowing provoked by drinking)
Timepoint [3] 444054 0
Patients were assessed for dysphagia (difficulty swallowing provoked by drinking)only upon discharge from the recovery unit.

Eligibility
Key inclusion criteria
The study included 80 patients in ASA physiological classification groups I-II, aged
18-65 years, undergoing elective surgery, not requiring muscle relaxants, with operation duration less than 2 hours and 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 and
probability of difficult airway (Mallampati class 3-4, sternomental distance less than 12 cm, thyromental distance less than 6 cm, head extension below 90 degrees, and mouth opening less than 1.5 cm),who were morbidly obese, with history of lung disease, with allergy to the study drugs, with history of alcohol and drug dependence, history of chronic sedative and opioid use, throat pain, dysphagia or dysphonia were excluded from 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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics (mean, standard deviation, median, minimum, maximum) were used to describe continuous variables. The distribution of categorical variables was presented using frequencies and percentages. The normality of the data distribution was assessed using the Kolmogorov-Smirnov test. The
comparing two independent continuous variables that did not follow a normal distribution was analyzed using the Mann-Whitney U test. Paired sample t test was used in the comparison between two dependent continuous variables.. The relationship between categorical variables was examined using the Chi-Square test (or Pearson / Fisher&#39;s Exact test, where appropriate). The effect of time in groups was examined with Repeated Measures ANOVA test. A p-value of less than 0.05 was considered statistically significant. The analyses were performed using MedCalc Statistical Software version 12.7.7 (MedCalc Software bvba, Ostend, Belgium; http://www.medcalc.org; 2013).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/01/2014
Date of last participant enrolment
Anticipated
Actual
15/07/2014
Date of last data collection
Anticipated
Actual
15/07/2014
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 26683 0
Turkey
State/province [1] 26683 0

Funding & Sponsors
Funding source category [1] 317768 0
Hospital
Name [1] 317768 0
Okmeydani Education and Research Hospital
Country [1] 317768 0
Turkey
Primary sponsor type
University
Name
Firat University School of Medicine Hospital
Address
Country
Turkey
Secondary sponsor category [1] 320858 0
None
Name [1] 320858 0
Address [1] 320858 0
Country [1] 320858 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316455 0
Okmeydani Education and Research Hospital of Medicine Drug Research Local Ethics Committee
Ethics committee address [1] 316455 0
Ethics committee country [1] 316455 0
Turkey
Date submitted for ethics approval [1] 316455 0
24/10/2013
Approval date [1] 316455 0
21/11/2013
Ethics approval number [1] 316455 0
132- 05.11.2013

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

Contacts
Principal investigator
Name 137942 0
A/Prof MENSURE ÇAKIRGÖZ
Address 137942 0
University of Health Sciences, Izmir Tepecik Training and Research Hospital, Department of Anesthesiology and Reanimation, Intensive Care Unit, Güney Neighborhood, 1140/1 Street, No: 1, Yenisehir, Konak, Izmir, 35120, Turkey
Country 137942 0
Turkey
Phone 137942 0
+905066906977
Fax 137942 0
Email 137942 0
[email protected]
Contact person for public queries
Name 137943 0
MENSURE ÇAKIRGÖZ
Address 137943 0
University of Health Sciences, Izmir Tepecik Training and Research Hospital, Department of Anesthesiology and Reanimation, Intensive Care Unit, Güney Neighborhood, 1140/1 Street, No: 1, Yenisehir, Konak, Izmir, 35120, Turkey
Country 137943 0
Turkey
Phone 137943 0
+905066906977
Fax 137943 0
Email 137943 0
[email protected]
Contact person for scientific queries
Name 137944 0
MENSURE ÇAKIRGÖZ
Address 137944 0
University of Health Sciences, Izmir Tepecik Training and Research Hospital, Department of Anesthesiology and Reanimation, Intensive Care Unit, Güney Neighborhood, 1140/1 Street, No: 1, Yenisehir, Konak, Izmir, 35120, Turkey
Country 137944 0
Turkey
Phone 137944 0
+905066906977
Fax 137944 0
Email 137944 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24319Ethical approval    CamScanner 15.09.2024 16.04.pdf



Results publications and other study-related documents

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