Back to resultsDexmedetomidine vs Fentanyl on Time to Extubation in Patients Undergoing Laparoscopic Sleeve Gastrectomy
Primary Purpose
Dexmedetomidine, Fentanyl, Time to Extubation
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Group F (fentanyl group)
Group D (dexmedetomidine group)
Sponsored by
About this trial
This is an interventional treatment trial for Dexmedetomidine
Eligibility Criteria
Inclusion Criteria: Age from 20 to 50 years old. Both sexes. American Standards Association (ASA) physical status II - III. Body Mass Index (BMI) ≥ 35 kg/m2. Exclusion Criteria: Allergy to α2 -adrenergic agonist. History of cardiac disease (uncontrolled hypertensive patient with blood pressure above 140/90, implanted pacemaker, poor cardiac function (ejection fraction< 50%), history of myocardial infarction, cerebral stroke, transient ischemic attack, or coronary artery disease with or without stents. Neuromuscular disease, liver disease (coagulopathy INR>1.5 or platelet count <100.000/μl), renal impairment (serum creatinine >1.2mg/dl, serum K >5.5mmol/l). Opioid medication within 24 hours before the operation. Respiratory diseases as COPD, uncontrolled asthmatic patients.
Sites / Locations
- Helwan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group F (fentanyl group)
Group D (dexmedetomidine group)
Arm Description
Fentanyl (1 μg/kg) was given intravenously slowly over 60 seconds before induction of anesthesia as a loading dose followed by continuous infusion at a rate of (1μg/kg/hr) after intubation. It was stopped 10 minutes before the end of surgery.
The patients were received a loading dose of dexmedetomidine (1 μg/kg) intravenously over 15 minutes before induction of anesthesia, followed by continuous infusion at a rate of (0.6 μg/ kg/ hr) after intubation and was stopped 10 minutes before the end of surgery.
Outcomes
Primary Outcome Measures
The time for extubation
Time from end of anesthesia till safe extubation of the patients
Secondary Outcome Measures
Mean arterial blood pressure (MAP)
Mean arterial blood pressure will be recorded (baseline, after induction, after tracheal intubation, at trochers insertion, during insufflation, at regular intervals throughout the surgery (every 5 minutes) until the end of surgery.
Heart rate (HR)
Heart rate will be recorded (baseline, after induction, after tracheal intubation, at trochers insertion, during insufflation, at regular intervals throughout the surgery (every 5 minutes) until the end of surgery.
Incidence of hypotension
Mean arterial blood pressure (MAP)<60mmHg. Ephedrine (5 mg) and 250 ml fluid bolus will be given if MAP < 60 mmHg or decrease 20% of the baseline value.
Full Information
NCT ID
NCT06052111
First Posted
September 18, 2023
Last Updated
September 18, 2023
Sponsor
Helwan University
1. Study Identification
Unique Protocol Identification Number
NCT06052111
Brief Title
Dexmedetomidine vs Fentanyl on Time to Extubation in Patients Undergoing Laparoscopic Sleeve Gastrectomy
Official Title
Dexmedetomidine Versus Fentanyl on Time to Extubation in Patients With Morbid Obesity Undergoing Laparoscopic Sleeve Gastrectomy: A Randamized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helwan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to compare the efficacy of dexmedetomidine versus fentanyl during general anesthesia for patients with morbid obesity undergoing laparoscopic sleeve gastrectomy.
Detailed Description
The use of opioids in surgeries for patients with morbid obesity is controversial since they are known for having ventilatory depressing effects. Therefore, alternative analgesics are needed to improve anesthetic management for patients with obesity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dexmedetomidine, Fentanyl, Time to Extubation, Morbid Obesity, Laparoscopic Sleeve Gastrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group F (fentanyl group)
Arm Type
Experimental
Arm Description
Fentanyl (1 μg/kg) was given intravenously slowly over 60 seconds before induction of anesthesia as a loading dose followed by continuous infusion at a rate of (1μg/kg/hr) after intubation. It was stopped 10 minutes before the end of surgery.
Arm Title
Group D (dexmedetomidine group)
Arm Type
Experimental
Arm Description
The patients were received a loading dose of dexmedetomidine (1 μg/kg) intravenously over 15 minutes before induction of anesthesia, followed by continuous infusion at a rate of (0.6 μg/ kg/ hr) after intubation and was stopped 10 minutes before the end of surgery.
Intervention Type
Drug
Intervention Name(s)
Group F (fentanyl group)
Intervention Description
Fentanyl (1 μg/kg) was given intravenously slowly over 60 seconds before induction of anesthesia as loading dose followed by continuous infusion at a rate of (1μg/kg/hr) after intubation and was stopped 10 minutes before the end of surgery.
Intervention Type
Drug
Intervention Name(s)
Group D (dexmedetomidine group)
Intervention Description
The patients received loading dose of dexmedetomidine (1 μg/kg) (Precedex, Abbot Laboratories Inc., Abbot Park, IL, USA) intravenously over 15 minutes before induction of anesthesia followed by continuous infusion at a rate of (0.6 μg/ kg/ hr) after intubation and was stopped 10 minutes before the end of surgery.
Primary Outcome Measure Information:
Title
The time for extubation
Description
Time from end of anesthesia till safe extubation of the patients
Time Frame
30 minutes till end of surgery.
Secondary Outcome Measure Information:
Title
Mean arterial blood pressure (MAP)
Description
Mean arterial blood pressure will be recorded (baseline, after induction, after tracheal intubation, at trochers insertion, during insufflation, at regular intervals throughout the surgery (every 5 minutes) until the end of surgery.
Time Frame
Intraoperatively.
Title
Heart rate (HR)
Description
Heart rate will be recorded (baseline, after induction, after tracheal intubation, at trochers insertion, during insufflation, at regular intervals throughout the surgery (every 5 minutes) until the end of surgery.
Time Frame
Intraoperatively
Title
Incidence of hypotension
Description
Mean arterial blood pressure (MAP)<60mmHg. Ephedrine (5 mg) and 250 ml fluid bolus will be given if MAP < 60 mmHg or decrease 20% of the baseline value.
Time Frame
Intraoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age from 20 to 50 years old.
Both sexes.
American Standards Association (ASA) physical status II - III.
Body Mass Index (BMI) ≥ 35 kg/m2.
Exclusion Criteria:
Allergy to α2 -adrenergic agonist.
History of cardiac disease (uncontrolled hypertensive patient with blood pressure above 140/90, implanted pacemaker, poor cardiac function (ejection fraction< 50%), history of myocardial infarction, cerebral stroke, transient ischemic attack, or coronary artery disease with or without stents.
Neuromuscular disease, liver disease (coagulopathy INR>1.5 or platelet count <100.000/μl), renal impairment (serum creatinine >1.2mg/dl, serum K >5.5mmol/l).
Opioid medication within 24 hours before the operation.
Respiratory diseases as COPD, uncontrolled asthmatic patients.
Facility Information:
Facility Name
Helwan University
City
Helwan
State/Province
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD Sharing Time Frame
After the end of study for one year
IPD Sharing Access Criteria
The data will be available upon a reasonable request from the corresponding author.
Learn more about this trial
Dexmedetomidine vs Fentanyl on Time to Extubation in Patients Undergoing Laparoscopic Sleeve Gastrectomy
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