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

NCT07246447 | Active Not Recruiting DMC

• 1 other identifier: ketodex in obesity
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Morbid Obesity

Keywords

ketamine; dexmedatodine; obesity; sleeve gastrectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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.

  1st 24 hours postoperatively

• Postoperative pain scores assessed using the Numerical Rating Scale (NRS).

  1st 24 hours post operatively

Study Arms (2)

ketodex group

ACTIVE COMPARATOR

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

opioid based group

ACTIVE COMPARATOR

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)

Interventions

Fentanyl (IV) DRUG

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.

Also known as: opioiod based anesthesia

opioid based group

ketamine and dexmeditomidine combination DRUG

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.

Also known as: ketodex

ketodex group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Cairo University: lead
• Kasr El Aini Hospital: collaborator

Study Sites (1)

Cairo university hospitals

Cairo, Manial, 11965, Egypt

Location

MeSH Terms

Conditions

Obesity, Morbid; Obesity

Interventions

Ketamine; Fentanyl

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia , cairo university

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 24, 2025
• Study Start: November 11, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2025-11

Locations

EG (1)