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Trial registered on ANZCTR


Registration number
ACTRN12625000126415
Ethics application status
Approved
Date submitted
5/11/2024
Date registered
4/02/2025
Date last updated
4/02/2025
Date data sharing statement initially provided
4/02/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Comparison Of The Effects Of Thiopental-Dexmedetomidine And Thiopental-Remifentanil Combinations On Laryngeal Mask Airway Insertion
Scientific title
A Comparison Of The Effects Of Thiopental-Dexmedetomidine And Thiopental-Remifentanil Combinations On The Success Of Classical Laryngeal Mask Airway Insertion In Adults Undergoing Elective Surgery
Secondary ID [1] 313311 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
airway management 335659 0
anesthesia 335660 0
Condition category
Condition code
Anaesthesiology 332223 332223 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study included 80 patients between the ages of 18 and 65 who were in I-II group according to the American Society of Anaesthesiologists physiological classification, who would undergo elective surgery, who did not require muscle relaxation, whose operation time did not exceed 2 hours and who had indications for laryngeal mask airway (LMA) insertion. Standard monitoring [heart rate (HR), systolic arterial pressure (SBP), diastolic arterial pressure (DBP), mean arterial pressure (MAP), electrocardiography (ECG-Derivation II), peripheral oxygen saturation (SpO 2 )] was performed before induction of anesthesia. The depth of anesthesia was monitored using bispectral index [BIS-Vista™ (Aspect Medical Systems; Newton; MA, USA)] monitoring. An intravenous line was opened with a 20 G cannula through the dorsum of the hand and 7 ml.kg -1 saline infusion was administered. Patients were randomly assigned to 2 groups (Group D and Group R n=40 in each group) to receive 1 µg.kg -1 dexmedetomidine or 2 µg.kg -1 remifentanil using the closed envelope procedure. Coded test syringes were prepared by an independent anesthesiologist with 0.9% saline in a total volume of 50 mL and 20 mL, respectively. Injection of all syringes was performed by an assistant behind a drape to blind the anesthetist to the drug doses during LMA insertion and monitoring of parameters. Preparation and administration of drugs, insertion of the LMA and monitoring of parameters were performed by different anesthetists. Medical parameters were recorded. In this way, the anesthetist who placed the LMA, monitored the patient response to the LMA, and monitored and recorded the parameters was blinded to the administered drugs.
Intervention code [1] 329885 0
Treatment: Drugs
Comparator / control treatment
Group R patients received 0.9% NaCl infusion in the same volume. In the last 60 s of the 50 ml infusion, 2 µg.kg-1 remifentanil was infused to the patients in Group R over 60 s with an infusion pump after being completed to 20 ml with 0.9% NaCl.
Control group
Active

Outcomes
Primary outcome [1] 339798 0
laryngeal mask airway insertion conditions
Timepoint [1] 339798 0
LMA insertion conditions evaluate during the first attempt(after 2 minutes post drug induction)
Secondary outcome [1] 441383 0
Laryngeal mask airway insertion time
Timepoint [1] 441383 0
We recorded the time from the opening of the mouth to the first successful ventilation as the LMA insertion time.

Eligibility
Key inclusion criteria
The study included 80 patients between the ages of 18 and 65 who were in I-II group according to the ASA physiological classification, who would undergo elective surgery, who did not require muscle relaxation, whose operation time did not exceed 2 hours and who had 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 and upper respiratory tract pathology, difficult airway history and probability (Mallampati class 3-4, sternomental distance below 12 cm, thyromental distance below 6 cm, head extension below 90 degrees, mouth opening below 1.5 cm), with morbid obesity, history of pulmonary disease, history of allergy to study drugs, history of alcohol and substance abuse, history of chronic sedative and opioid analgesic use, sore throat, dysphagia, and dysphonia were excluded.

Study design
Purpose of the study
Treatment
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 using procedures like coin-tossing and dice-rolling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis
The criteria indicating successful insertion of the laryngeal mask were evaluated as: visualization of a square wave on the capnogram, easy ventilation with the breathing balon, visualization of chest movements and absence of any air leakage during ventilationlData 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 and presented with Mean Standard Deviation or median, interquartile range deviation (IQR).Shapiro Wilk test was used to examine the distribution assumptions of continuous variables according to groups.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 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 in comparisons between times. A value of p <0.05 was considered statistically significant.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
Actual
1/12/2013
Date of last participant enrolment
Anticipated
Actual
1/06/2014
Date of last data collection
Anticipated
Actual
1/08/2014
Sample size
Target
131
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 26673 0
Turkey
State/province [1] 26673 0

Funding & Sponsors
Funding source category [1] 317757 0
Hospital
Name [1] 317757 0
Istanbul Training and Research Hospital, Department of Anesthesiology and Reanimation, Istanbul, Turkey
Country [1] 317757 0
Turkey
Primary sponsor type
Hospital
Name
Istanbul Training and Research Hospital, Department of Anesthesiology and Reanimation, Istanbul, Turkey
Address
Country
Turkey
Secondary sponsor category [1] 320078 0
None
Name [1] 320078 0
Address [1] 320078 0
Country [1] 320078 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316448 0
Okmeydani Egitim ve arastirma Hastanesi Klinik Arastirmalar Etik Kurulu
Ethics committee address [1] 316448 0
Abdurrahman Tunay
Ethics committee country [1] 316448 0
Turkey
Date submitted for ethics approval [1] 316448 0
05/11/2013
Approval date [1] 316448 0
21/11/2013
Ethics approval number [1] 316448 0
131 - 05/11/2013

Summary
Brief summary
Thiopental is one of the oldest hypnotic agents used in anesthetic practice. However, alone it cannot provide adequate conditions for successful LMA insertion. For this purpose, many agents have been used as adjuvants to thiopental. The aim was to compare the effect of remifentanil or dexmedetomidine administration on LMA insertion conditions before induction with thiopental in a prospective, randomized, double-blind study. In our study, 2 µg.kg -1 remifentanil administration before induction
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137922 0
Mr Abdurrahman Tunay
Address 137922 0
Istanbul Training and Research Hospital, Department of Anesthesiology and Reanimation, Istanbul, Turkey, 34098
Country 137922 0
Turkey
Phone 137922 0
+905052309520
Fax 137922 0
Email 137922 0
[email protected]
Contact person for public queries
Name 137923 0
Abdurrahman Tunay
Address 137923 0
Istanbul Training and Research Hospital, Department of Anesthesiology and Reanimation, Istanbul, Turkey, 34098
Country 137923 0
Turkey
Phone 137923 0
+905052309520
Fax 137923 0
Email 137923 0
[email protected]
Contact person for scientific queries
Name 137924 0
Abdurrahman Tunay
Address 137924 0
Istanbul Training and Research Hospital, Department of Anesthesiology and Reanimation, Istanbul, Turkey,34098
Country 137924 0
Turkey
Phone 137924 0
+905052309520
Fax 137924 0
Email 137924 0
[email protected]

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
24313Ethical approval    388716-(Uploaded-05-11-2024-01-20-15)-CamScanner 15.09.2024 16.12.pdf



Results publications and other study-related documents

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