Dexmedetomidine, Fentanyl, Laparoscopic Sleeve Gastrectomy, Morbid Obesity, Time to Extubation
Conditions
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.
Interventions
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.
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.
Sponsors
Helwan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The time for extubation | 30 minutes till end of surgery. | Time from end of anesthesia till safe extubation of the patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean arterial blood pressure (MAP) | Intraoperatively. | 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) | Intraoperatively | 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 | Intraoperatively | 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. |
Countries
Egypt
Outcome results
None listed