Clinical trial NCT06738043: Dexmedetomidine Versus Ketamine as Adjuvants in Bariatric Surgery
Official title: Dexmedetomidine Infusion Versus Low Dose Ketamine Infusion as an Adjuvant in Bariatric Surgery: A Randomized Controlled Comparative Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Postoperative Pain
Bariatric Surgery
Keywords: Dexmedetomidine
Ketamine
Opioid-Sparing Analgesia
Randomized Controlled Trial
Pain Management
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized into three parallel groups: dexmedetomidine, ketamine, or control (placebo) groups, each receiving specific interventions based on the protocol.
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial aims to compare the analgesic efficacy of dexmedetomidine infusion versus low-dose ketamine infusion as adjuvants in bariatric surgery. The study includes 90 patients undergoing bariatric surgery at Menoufia University Hospital, randomized into three groups: dexmedetomidine, ketamine, and control (placebo). Primary outcomes include total morphine consumption intra- and post-operatively. Secondary outcomes include postoperative pain scores, total analgesic consumption, time to first analgesic request, hemodynamic parameters, and patient satisfaction. This study seeks to explore safer, more effective pain management strategies to minimize opioid use in bariatric surgery patients.

Detailed description: This study is a prospective, randomized controlled interventional trial evaluating the analgesic efficacy and opioid-sparing effects of dexmedetomidine and low-dose ketamine as adjuvants in bariatric surgery. Ninety patients meeting the inclusion criteria will be enrolled and randomized into three groups:

* Dexmedetomidine Group: Patients will receive a bolus dose of dexmedetomidine (0.5 µg/kg) followed by a continuous infusion (0.5 µg/kg/h) until 10 minutes before the end of surgery.
* Ketamine Group: Patients will receive a bolus dose of ketamine (0.3 mg/kg) followed by a continuous infusion (0.3 mg/kg/h) until 10 minutes before the end of surgery.
* Control Group: Patients will receive an equal volume of normal saline as a placebo.

Objectives

The primary objective is to compare intra- and postoperative morphine consumption between groups. Secondary objectives include:

* Pain assessment using the Numeric Rating Scale (NRS) at multiple time points postoperatively.
* Time to first request for rescue analgesia.
* Hemodynamic stability (heart rate and mean arterial pressure).
* Patient satisfaction assessed using a 5-point scale.
* Incidence of adverse effects such as nausea, vomiting, bradycardia, and respiratory depression.

Study Protocol All patients will undergo standard preoperative assessments, including history, physical examination, and laboratory investigations. General anesthesia will be induced and maintained per institutional protocols. Postoperatively, pain management will follow a stepwise approach, with intravenous paracetamol as rescue analgesia.

Significance Given the high prevalence of obesity-related comorbidities, bariatric surgery patients are at increased risk for postoperative complications, particularly with opioid use. This study addresses the need for opioid-sparing pain management strategies, potentially reducing the risks of opioid-related adverse effects and improving patient outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-60 years.
* Both sexes.
* Body mass index (BMI) \> 35 kg/m², scheduled for bariatric surgery.
* American Society of Anesthesiologists (ASA) physical status I-II.

Exclusion Criteria:

* History of hypersensitivity to dexmedetomidine or ketamine.
* History of substance abuse or chronic opioid use.
* American Society of Anesthesiologists (ASA) physical status III or IV.
* Severe hepatic or renal impairment.
* Cardiopulmonary disorders.
* Severe diabetes mellitus.
* Psychiatric disorders, seizures, uncontrolled hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg), or heart block.

Primary outcomes:
measure: Total Morphine Consumption Intra- and Postoperatively
timeFrame: From the start of anesthesia to 24 hours postoperatively
Secondary outcomes:
measure: Postoperative Pain Scores (Numeric Rating Scale - NRS)
timeFrame: At 1, 2, 4, 8, 12, 16, and 24 hours postoperatively
measure: Time to First Request for Rescue Analgesia
timeFrame: 24 hours postoperatively
measure: Hemodynamic Stability (Heart Rate)
timeFrame: From baseline (pre-surgery) to 24 hours postoperatively
measure: Hemodynamic Stability (Mean Arterial Pressure)
timeFrame: From baseline (pre-surgery) to 24 hours postoperatively
measure: Total Analgesic Consumption (Other Than Morphine)
timeFrame: At 24 hours postoperatively
measure: Patient Satisfaction with Pain Management
timeFrame: At 24 hours postoperatively
Other outcomes:
Locations:
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