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Dexmedetomidine for Postoperative Analgesia After Bariatric Surgery

Intraoperative Dexmedetomidine Versus Morphine for Postoperative Analgesia After Laparoscopic Bariatric Surgery

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02213159
Enrollment
60
Registered
2014-08-11
Start date
2014-07-31
Completion date
2015-12-31
Last updated
2016-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Hypertension, Obesity, Sleep Apnea

Keywords

Dexmedetomidine, bariatric surgery, postoperative pain, morphine consumption, Quality of recovery

Brief summary

The purpose of this study is to determine if Dexmedetomidine given at the end of surgery will reduce postoperative morphine consumption and improve postoperative quality of recovery as compared to morphine in patients undergoing laparoscopic bariatric surgery.

Detailed description

effect of Dexmedetomidine bolus on postoperative morphine requirements

Interventions

DRUGDexmedetomidine
DRUGMorphine

Sponsors

American University of Beirut Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Body Mass Index \> 40 kg/m2 or BMI \> 35 kg/m2 with comorbid conditions such as hypertension, diabetes or sleep apnea * American Society of Anesthesiologists class I or II * Undergoing laparoscopic sleeve gastrectomy bariatric surgery

Exclusion criteria

* 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 * pregnant or breastfeeding.

Design outcomes

Primary

MeasureTime frame
Total dose of morphine consumed in Post Anesthesia Care Unit (PACU)At discharge from the PACU

Secondary

MeasureTime frame
Numeric Rating Scale (NRS) for Painin the PACU and at 24 hours
NRS for nauseain the PACU
incidence of pruritusin the PACU
incidence of vomiting or retchingin the PACU
Time to first morphine requirement in PACUin the PACU
time to discharge readiness in PACUin the PACU
total morphine consumption at 24 hoursat 24 hours
Quality of Recovery (QoR-40) score at 24 hoursat 24 hours
overall satisfaction at one monthone month after surgery
incidence of respiratory complicationsin the PACU

Countries

Lebanon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026