Ketodex Versus Opioid Based Anesthesia in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy. (Ketodex)

Opioid Sparing Anesthesia Using Ketodex Versus Opioid Based Anesthesia in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy: A Randomized Controlled Trial.

comparing Opioid sparing anesthesia using ketodex versus opioid based anesthesia in obese patients undergoing laparoscopic sleeve gastrectomy.

Study Overview

• Status: Active, not recruiting
• Conditions: Morbid Obesity
• Intervention / Treatment: Drug: ketamine and dexmeditomidine combination; Drug: Fentanyl (IV)

Detailed Description

Bariatric surgery has seen a substantial increase, especially among patients with medically complex obesity who struggle to lose weight with traditional approaches . Although advances in anesthetic procedures enhance surgical and clinical outcomes, regular opioid usage in bariatric surgeries might result in adverse effects such as drowsiness, postoperative nausea and vomiting (PONV), respiratory depression, and impaired gastrointestinal motility. These adverse effects increase the risk of postoperative cardiac and respiratory complications .

The key to managing such patients is the utilization of a novel form of anesthesia and analgesia, known as opioid-sparing anesthesia, which has recently been developed to ensure better outcomes . During opioid-sparing anesthesia, the sympathetic nervous system is inhibited by means other than opioid delivery . Such techniques include the use of medications from the alpha-2 agonist group, lidocaine, ketamine, magnesium sulfate, beta-blockers, or gabapentinoids .

Ketamine is an N-methyl-D-aspartate antagonist with analgesic and anti-hyperalgesic properties at low doses . This drug prevents the development of opioid tolerance by minimizing opioid use while reducing postoperative pain, ultimately decreasing opioid-related postoperative morbidity .

Dexmedetomidine, a highly selective α2-adrenoceptor agonist, is used as an adjuvant analgesic in the perioperative period . It improves hemodynamic stability and reduces the stress induced by intubation due to its central sympatholytic action . Furthermore, it decreases the need for opioids and anesthetics, providing additional benefits for obese patients .

By lowering the required dosages, adding a low dose of ketamine to dexmedetomidine is thought to result in less toxicity than using either medication alone . Vishnuraj et al. concluded that the combination of ketamine and dexmedetomidine effectively reduced postoperative opioid consumption; however, their approach involved the use of ketamine as a bolus following induction, in conjunction with a continuous infusion of dexmedetomidine in adults undergoing laparoscopic cholecystectomy .

To the best of our knowledge, the use of both ketamine and dexmedetomidine infusion versus opioid-based anesthesia among patients undergoing bariatric surgery, specifically regarding postoperative pain, has not been previously compared

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Manial
    • Cairo, Manial, Egypt, 11965
      • Cairo University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult patients (>18 years) undergoing Elective Bariatric Surgery .

  • American Society of Anesthesiologists physical status class II or III .
  • body mass index (BMI) > 35 kg/m2 .

Exclusion Criteria:

• • Refusal to participate .

  • Any sensitivity or contraindication to ketamine or dexmedotomidine .
  • Pregnancy or breast feeding .
  • Patients with significant renal impairment .
  • Any patient on regular intake of beta blockers or calcium channel blockers .
  • CNS disorders eg: seizures , raised intra cranial tension .
  • Chronic opioid use.
  • Obese patients with STOP bang score more than 5 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ketodex group; Group KD: Two syringes containing ketodex-ketamine (1 mg/kg) and dexmedetomidine (1 µg/kg)-each diluted with 0.9% saline and infused over 10 minutes. Maintenance will consist of continuous low-dose infusion of ketamine (0.3 mg/kg/h) and dexmedetomidine (0.5 µg/kg/h) in separate syringes until 15 minutes before the end of surgery.	Drug: ketamine and dexmeditomidine combination; Group KD: Two syringes containing ketodex-ketamine (1 mg/kg) and dexmedetomidine (1 µg/kg)-each diluted with 0.9% saline and infused over 10 minutes. Maintenance will consist of continuous low-dose infusion of ketamine (0.3 mg/kg/h) and dexmedetomidine (0.5 µg/kg/h) in separate syringes until 15 minutes before the end of surgery.; Other Names: ketodex
Active Comparator: opioid based group; Group OP: Two syringes-one containing fentanyl (2 µg/kg) and the other 0.9% saline-infused over 10 minutes. Maintenance will be provided by two continuous saline infusions, prepared to mimic the ketodex infusions, until 15 minutes before the end of surgery.	Drug: Fentanyl (IV); Group OP: Two syringes-one containing fentanyl (2 µg/kg) and the other 0.9% saline-infused over 10 minutes. Maintenance will be provided by two continuous saline infusions, prepared to mimic the ketodex infusions, until 15 minutes before the end of surgery.; Other Names: opioiod based anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total nalbuphine consumption (mg) during the first 24 hours postoperatively.	Total nalbuphine consumption (mg) during the first 24 hours postoperatively.	during the first 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total intraoperative titrated fentanyl dose for each patient.		intraoperative time
Time to extubation, defined as the interval between discontinuation of anesthesia and tracheal extubation		the interval between discontinuation of anesthesia and tracheal extubation
• Time to first postoperative rescue analgesia		during 1st 24 hrs postoperatively.
Postoperative sedation scores.	Sedation assessment: All patients will be monitored postoperatively in the post-anesthesia care unit (PACU) and ward. Sedation will be assessed using the Modified Observer's Assessment of Alertness/Sedation Scale (MOASS) . Scores will be recorded at 0, 10, 30, and 60 minutes from PACU admission.	1st 24 hours postoperatively
Postoperative pain scores assessed using the Numerical Rating Scale (NRS).	Postoperative pain: Pain will be assessed using the Numerical Rating Scale (NRS, 0 = no pain, 10 = worst pain). Patients will be instructed preoperatively regarding the scale. NRS scores will be recorded at 0, 30, and 60 minutes, and at 2, 6, 12, and 24 hours after surgery.	1st 24 hours post operatively
Postoperative nausea and vomiting (PONV) scores	by using Simplified PONV Impact Scale (SPONVIS) This simplified version, often used for audit and post-discharge review, uses just two main components: Nausea Impact and Vomiting Impact.; Nausea Impact," Based on the patient's assessment of how much the nausea affected their recovery (e.g., ability to eat, walk, or be discharged).","0 to 5 Points (e.g., 0 = No Impact, 5 = Severe Impact/Required hospital stay)"; Vomiting/Retching, Total number of vomiting or retching episodes.,"0 to 5 Points (e.g., 0 = None, 5 = ≥3 episodes)" Total SPONVIS Score Sum of Nausea Impact + Vomiting/Retching Points, Score: 0 to 10 Cut-off for CIPONV Total Score ≥5	1st 24 hours postoperatively
Patient satisfaction scores .	(0 = not satisfied, 10 = highly satisfied).	during 1st 24 hours postoperatively.
Length of hospital stay	From date of randomization until the date of first documented progression	1-2 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: obesity; ketamine; sleeve gastrectomy; dexmedatodine
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Obesity, Morbid; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Piperidines; Ketamine; Fentanyl
• Other Study ID Numbers: ketodex in obesity

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No