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Trial registered on ANZCTR


Registration number
ACTRN12625000175471
Ethics application status
Approved
Date submitted
8/11/2024
Date registered
14/02/2025
Date last updated
14/02/2025
Date data sharing statement initially provided
14/02/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Adding Remifentanil to Thiopental Anaesthesia Induction on Classic Laryngeal Mask Airway Insertion Success: A Randomized Double-Blind Clinical Trial
Scientific title
Effect of Adding Remifentanil to Thiopental Anaesthesia Induction on Classic Laryngeal Mask Airway Insertion Success in ASA I-II Patients Undergoing Elective Surgery: A Randomized Double-Blind Clinical Trial
Secondary ID [1] 313332 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anesthesiology Airway management 335690 0
Anaesthesiology 335691 0
Condition category
Condition code
Anaesthesiology 332253 332253 0 0
Anaesthetics
Anaesthesiology 332254 332254 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study received approval from the Okmeydani Education and Research Pharmaceutical Research Local Ethics Committee (decision number 110), and informed consent was obtained from all patients. Conducted from October 2013 to December 2013, the study included 100 ASA class I-II patients, aged 18-65 years, undergoing elective surgery without muscle relaxants, with operations lasting no more than 2 hours, and requiring LMA insertion.

Patients with conditions such as neck or upper respiratory tract pathologies, high aspiration risk, morbid obesity, or difficult airway indicators (e.g., Mallampati class 3-4, limited neck mobility), along with those with histories of pulmonary disease, allergies to study medications, or substance dependence, were excluded.

Standard monitoring included ECG (lead II), non-invasive blood pressure (SAP, DAP, MAP), SpO2, respiratory rate, end-tidal CO2, and inspired oxygen concentration. Anaesthesia depth was measured using a bispectral index (BIS-Vista™, Aspect Medical Systems, Newton, MA, USA). Patients received preoxygenation with 6 L/min oxygen, followed by IV midazolam (0.03 mg/kg).

Patients were randomly assigned to four groups (n=25 per group) receiving 0.5, 1, 2, or 3 µg/kg remifentanil via coded syringes prepared by an independent anaesthesiologist. Remifentanil was infused over 60 seconds with an infusion pump (Braun Infusomat®). Thirty seconds after starting remifentanil, thiopental (5 mg/kg) was administered over 30 seconds. LMA was inserted 90 seconds after thiopental administration, provided BIS values were below 40 and adequate jaw relaxation was achieved.

The conditions for LMA insertion were assessed using a 6-variable scale evaluating chin opening, ease of insertion, swallowing, coughing, laryngospasm, and patient movement. Outcomes were categorized as excellent, satisfactory, or poor. Hemodynamic parameters (SAP, DAP, MAP, HR, BIS, SpO2) were recorded at baseline, 1 minute before LMA insertion, and at 1, 2, 3, 4, and 5 minutes after insertion.

Postoperative assessments included the presence of blood after LMA removal and evaluations for throat pain and dysphagia upon discharge from the recovery unit. Throat pain was scored from 0 (no complaints) to 3 (severe pain). Dysphagia was assessed as difficulty swallowing provoked by drinking.
Intervention code [1] 329914 0
Treatment: Drugs
Intervention code [2] 329915 0
Treatment: Devices
Comparator / control treatment
This study did not include a control group. Instead, comparisons were made among the four groups receiving different doses of remifentanil (0.5, 1, 2, and 3 µg.kg^-1). The primary comparisons focused on the effects of these doses on laryngeal mask airway (LMA) insertion conditions, hemodynamic changes, and apnea duration. The study aimed to identify the optimal dose of remifentanil by evaluating its efficacy across these parameters without the use of a separate control group.
Control group
Dose comparison

Outcomes
Primary outcome [1] 339825 0
the effect of different doses of remifentanil, 0.5, 1, 2 or 3 µg.kg-1, with 5 mg.kg-1 thiopental induction on LMA insertion conditions and success, and to determine the optimal remifentanil dose for successful LMA insertion with a prospective, randomized and double-blind, clinical study.
Timepoint [1] 339825 0
LMA insertion conditions were assessed immediately following the completion of the LMA insertion. Ninety seconds after thiopental administration, patients with a BIS value below 40 and sufficient jaw relaxation underwent LMA insertion. The conditions were then rated based on predefined criteria, including mouth opening, ease of insertion, and patient response.
Primary outcome [2] 339826 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] 339826 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] 441529 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] 441529 0
The presence of blood was assessed immediately after removing the laryngeal mask (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 100 patients in class I-II according to ASA physical status classification, aged 18-65 years, undergoing elective surgery, without requiring muscle relaxant, with operation duration not exceeding 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
Patients with any neck or upper respiratory tract pathology, gastric content regurgitation-aspiration risk,history or probability 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), who were morbidly obese, had history of pulmonary disease, allergy to the study medications, history of alcohol and substance abuse, history of chronic sedative and opioid analgesic use, adrenocortical insufficiency, sore throat, 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
Safety/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 were assessed using the Shapiro-Wilk test and Kolmogorov-Smirnov test. The relationship between more than two independent continuous variables that did not follow a normal distribution was analyzed using Kruskal-Wallis test. For parameters with significant results, post-hoc pairwise comparisons were conducted using the Bonferroni-corrected Mann-Whitney U test. The relationship between categorical variables was examined using the Chi-Square test (or Yates' Continuity Correction / Fisher's Exact test, where appropriate). The time effect in the groups was examined with Repeated Measures ANOVA test. A p-value of less than 0.05 was considered statistically significant. Data were evaluated using IBM SPSS Statistics 26.0 (IBM Corp., Armonk, New York, USA) statistical package program.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/10/2013
Date of last participant enrolment
Anticipated
Actual
15/06/2014
Date of last data collection
Anticipated
Actual
15/06/2014
Sample size
Target
120
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 26707 0
Turkey
State/province [1] 26707 0
Country [2] 26708 0
Turkey
State/province [2] 26708 0

Funding & Sponsors
Funding source category [1] 317784 0
Hospital
Name [1] 317784 0
Okmeydani Education and Research Hospital
Country [1] 317784 0
Turkey
Primary sponsor type
Hospital
Name
Firat University School of Medicine Hospital
Address
Country
Turkey
Secondary sponsor category [1] 320857 0
None
Name [1] 320857 0
Address [1] 320857 0
Country [1] 320857 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316468 0
Okmeydani Education and Research Hospital of Medicine Drug Research Local Ethics Committee
Ethics committee address [1] 316468 0
Ethics committee country [1] 316468 0
Turkey
Date submitted for ethics approval [1] 316468 0
22/08/2013
Approval date [1] 316468 0
24/09/2013
Ethics approval number [1] 316468 0
110- 03/09/2013

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

Contacts
Principal investigator
Name 137986 0
A/Prof Mensure Cakirgoz
Address 137986 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 137986 0
Turkey
Phone 137986 0
+905066906977
Fax 137986 0
Email 137986 0
drmensure@gmail.com
Contact person for public queries
Name 137987 0
MENSURE ÇAKIRGÖZ
Address 137987 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 137987 0
Turkey
Phone 137987 0
+905066906977
Fax 137987 0
Email 137987 0
drmensure@gmail.com
Contact person for scientific queries
Name 137988 0
MENSURE ÇAKIRGÖZ
Address 137988 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 137988 0
Turkey
Phone 137988 0
+905066906977
Fax 137988 0
Email 137988 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
24320Ethical approval    388732-(Uploaded-08-11-2024-06-00-07)-CamScanner 15.09.2024 15.50.pdf



Results publications and other study-related documents

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