Background: Dexmedetomidine
is an alpha2 receptor agonist with sedative and analgesic sparing
properties. Unlike opioids it is not associated with respiratory depression.
Although it is only FDA approved for use as a sedative in the intensive care unit,
it has become a popular adjuvant during anesthesia for major surgeries. Among
them, laparoscopic bariatric surgery has seen its incidence increase in
parallel to the rising number of morbid obese. The use of dexmedetomidine as an
adjuvant during laparoscopic bariatric surgery may reduce postoperative opioid requirements
and spare the patient of their side effects (nausea, vomiting, respiratory
depression, itching…) thereby improving the quality of recovery. These side
effects are especially deleterious and to be avoided in morbidly obese patients
in which comorbidities are frequent (obstructive sleep apnea, gastroesophageal
reflux, hypertension…)
Specific Aim: we
aim to compare the effect of dexmedetomidine vs. morphine administered 30 minutes
before the anticipated completion of laparoscopic bariatric surgery (sleeve
gastrectomy) on patient opioid requirements in the post-anesthesia care unit (PACU)
and the quality of recovery.
Methodology: This
is a prospective, block randomized double-blind clinical trial. Consenting patients
will be divided into two groups. Thirty minutes before the anticipated
completion of the surgery, patients will be given either morphine sulfate (bolus
0.08 mg/kg over 10 minutes followed by an infusion of saline) (Group M) or
dexmedetomidine (an initial loading dose of 1 µg/kg over 10 minutes followed by
0.5 µg/kg/h) (Group D). Study drug
doses will be calculated according to patients’ actual body weight. Postoperatively,
patients’ pain will be treated using a patient controlled analgesia machine (PCA)
delivering morphine. In the PACU, morphine consumption, numeric rating scale (NRS)
for pain and nausea, heart rate, blood pressure, vomiting, retching, itching and
sedation score will be compared between the two groups. Quality of recovery
scores will be assessed and compared at 24 hours. Overall satisfaction will be
collected at one month.
Analysis:
morphine consumption in PACU (primary
outcome) will be compared between the two groups. Data will be presented as
a mean ± SD or numbers and percentages. Statistical analysis will be performed using
the Chi-square test, Fisher’s exact test or the Mann-Whitney U-test as appropriate. A P value <0.05 will be considered
significant.
Significance: Given
the rising prevalence of laparoscopic bariatric surgery combined with the increased
risks and side effects associated with high opioid dosing to treat postoperative
pain, we believe this study will have a high impact on the opioid requirements
and quality of recovery of morbidly obese patients and might change some of the
protocols used for their management.
Morbidly obese inpatients scheduled for bariatric surgeries at AUBMC
Random Sampling
Morbidly
obese males or females aged between 18 and 60 y with a BMI > 40 kg/m2
or BMI > 35 kg/m2 with comorbid conditions such as hypertension, diabetes
or sleep apnea; ASA I or II undergoing laparoscopic sleeve gastrectomy bariatric
surgery.
Allergy
to morphine or its derivatives, allergy to α-2 adrenergic agonists,
weight over 180 kg, history of uncontrolled hypertension, heart block greater
than first degree,prolonged QT interval,clinically significant neurologic, cardiovascular, renal,
hepatic, or gastrointestinal diseases, received an opioid analgesic medication
within a 24 h period prior to surgery, history of alcohol, drug abuse or
chronic opioid intake, history of psychiatric disorder and pregnant or
breastfeeding.