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Dexmedetomidine Versus Ketamine as Adjuvants in Bariatric Surgery

ConditionsObesityPostoperative PainBariatric Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorTanta University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine infusion

    Drug

    A bolus dose of dexmedetomidine (0.5 µg/kg ideal body weight) diluted in 0.9% normal saline is infused over 10 minutes before induction of anesthesia, followed by a continuous infusion at 0.5 µg/kg/h until 10 minutes before the end of surgery.

  • Ketamine infusion

    Drug

    A bolus dose of ketamine (0.3 mg/kg ideal body weight) diluted in 0.9% normal saline is infused over 10 minutes before induction of anesthesia, followed by a continuous infusion at 0.3 mg/kg/h until 10 minutes before the end of surgery.

  • Normal Saline Infusion (Placebo)

    Drug

    A bolus dose of 0.9% normal saline is infused over 10 minutes before induction of anesthesia, followed by a continuous infusion of 0.9% normal saline until 10 minutes before the end of surgery.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Dexmedetomidine GroupExperimental treatment 1 intervention
Group B: Ketamine GroupExperimental treatment 1 intervention
Group C: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Total Morphine Consumption

The total dose of morphine, measured in mg, administered to each participant during the first 24 hours postoperatively for pain control.

Time frame
Within the first 24 hours postoperatively

Secondary outcomes

1

Postoperative Pain Scores (Numeric Rating Scale - NRS)

Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores will be recorded at specific intervals postoperatively (1, 2, 4, 8, 12, 16, and 24 hours).

Time frame
At 1, 2, 4, 8, 12, 16, and 24 hours postoperatively
2

Time to First Request for Rescue Analgesia

The duration (in hours) from the end of surgery to the first request for rescue analgesia (intravenous morphine) by the participant.

Time frame
24 hours postoperatively
3

Hemodynamic Stability (Heart Rate)

Heart rate (HR) will be monitored and recorded at specific intervals during and after surgery to assess hemodynamic stability.

Time frame
From baseline (pre-surgery) to 24 hours postoperatively
4

Hemodynamic Stability (Mean Arterial Pressure)

Mean arterial pressure (MAP) will be monitored and recorded at specific intervals during and after surgery to assess hemodynamic stability.

Time frame
From baseline (pre-surgery) to 24 hours postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Menoufia University

Sponsor institution

Source ClinicalTrials.gov

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