Ketamine Infusion vs Dexmedetomidine Infusion in Obese Patients Undergoing Bariatric Surgery

Ain Shams University

Status and phase: Unknown; Phase 3

Conditions: Surgery; Morbid Obesity

Treatments: Drug: Normal Saline 0.9%; Drug: Ketamine; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04576975

FMASU M D 108 / 2020

Details and patient eligibility

About

The surgeries that involve treatment of morbid obesity, i.e. bypass procedure and sleeve gastrectomy, are collectively covered under the term 'bariatric surgery'. The frequency of bariatric surgery has been increasing worldwide for patients with medically complicated obesity who have difficulty losing weight by other methods

The growth of bariatric surgery is accompanied with development of anesthetic techniques to maintain patient safety and improve outcome. Treatment with narcotics in obese patients has dual effect. Increased use of narcotics are associated with multiple complications including Postoperative Nausea and Vomiting (PONV) , respiratory depression and elevated risk of Obstructive Sleep Apnea (OSA) complications . On the other hand, the reduction in opioid use may result in acute post-operative pain that may limit post-surgery rehabilitation. Therefore, we need to minimize opioid use and employ some other drugs which, besides having analgesia, has an opioid-sparing effect also.

Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has analgesic properties in sub-anesthetic doses. When used in low dose (0.3 to 0.5 mg/kg) by ideal body weight, it is an analgesic, anti-hyperalgesic, and prevents development of opioid tolerance.

Dexmedetomidine is selective α2-Adrenoceptor agonist that has been used as an adjuvant to anesthetic agents in perioperative period for several adventitious profile as well as tolerated side effects . While dexmedetomidine is emerging as a beneficial adjunct to the analgesic regimen in the perioperative period, its utilization is not routinely widespread .

Enrollment: 90 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI > 35 kg/m2
• ASA physical status II & III (according to BMI)
• Undergoing laparoscopic bariatric surgery

Exclusion criteria

• Patients refusal
• ASA physical status: IV (according to BMI)
• History of hypersensitivity to dexmedetomidine and/or ketamine
• History of substance abuse (Benzodiazepines) or Chronic opioid use
• Psychiatric or Seizure disorder
• uncontrolled hypertension or heart block
• uncontrolled diabetes
• Surgical Complication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Ketamine

Experimental group

Description:

This group will receive a bolus dose of Ketamine \[Ketamine HCL - Sterop, Belgium\] (0.3 mg/kg) by the ideal body weight diluted with 0.9% Normal Saline over 10 minutes by 20 ml syringe infused before induction. After which Ketamine infusion (500 mg vial diluted over 50 cc infusion syringe, concentration 10 mg/ml) will start with rate of 0.3 mg/kg/hr till 10 Minutes before the end of the surgery

Treatment:

Drug: Ketamine

Dexmedetomidine

Experimental group

Description:

This group will receive a bolus dose of Dexmedetomidine \[Precedex® -Hospira, USA\] (0.5 µcg/kg) by the ideal body weight diluted with 0.9% Normal Saline over 10 minutes by 20 ml syringe infused before induction. After which, the Dexmedetomidine infusion (200 µcg vial diluted over 50 cc infusion syringe, concentration 4 µcg/ml) will start with rate of 0.5 µcg/kg/hr till 10 Minutes before the end of the surgery

Treatment:

Drug: Dexmedetomidine

Normal Saline 0.9%

Placebo Comparator group

Description:

This group will receive a bolus dose of NS 0.9% over 10 minutes by 20 ml syringe infused before induction. After which, NS 0.9% (50 ml over 50 cc syringe) will be infused.

Treatment:

Drug: Normal Saline 0.9%