Clinical trial NCT04576975: Ketamine Infusion vs Dexmedetomidine Infusion in Obese Patients Undergoing Bariatric Surgery
Official title: Perioperative Use of Ketamine Infusion vs Dexmedetomidine Infusion as Analgesic in Obese Patients Undergoing Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Morbid Obesity
Surgery
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Kuwait
First posted: 2020-10-06
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 .


Eligibility criteria: 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

Primary outcomes:
measure: compare the use of ketamine versus dexmedetomidine when used as perioperative infusion in obese patients undergoing laparoscopic bariatric surgery regarding their analgesic efficacy
timeFrame: one year throughout the study
Secondary outcomes:
measure: any side effects or drawbacks (PONV and effects on consciousness) that might associate with their use
timeFrame: one year throughout the study
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams University Hospitals
Study officials:
affiliation: Ainshams University, Egypt
name: Bahaa El-Din E Ali, PhD
role: STUDY_DIRECTOR
affiliation: Ainshams University, Egypt
name: Ahmed N El-Shaer, PhD
role: STUDY_DIRECTOR
affiliation: Ministry of Health, Kuwait
name: Mohammad A Khaja, FCARCSI
role: STUDY_DIRECTOR
affiliation: Ainshams University, Egypt
name: Mohammed O Taeimah, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ainshams University, Egypt
name: Maha S Al Derh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ainshams University, Egypt
name: Belal N Khalil, M.Sc
role: PRINCIPAL_INVESTIGATOR
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