Cairo university hospitals
Cairo, Manial, 11965, Egypt
NCT Number: NCT07246447
comparing Opioid sparing anesthesia using ketodex versus opioid based anesthesia in obese patients undergoing laparoscopic sleeve gastrectomy.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Cairo, Manial, 11965, Egypt
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: during the first 24 hours postoperatively
Total nalbuphine consumption (mg) during the first 24 hours postoperatively.
Time frame: intraoperative time
Time frame: the interval between discontinuation of anesthesia and tracheal extubation
Time frame: during 1st 24 hrs postoperatively.
Time frame: 1st 24 hours postoperatively
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.
Time frame: 1st 24 hours post operatively
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.
Time frame: 1st 24 hours postoperatively
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.
Time frame: during 1st 24 hours postoperatively.
(0 = not satisfied, 10 = highly satisfied).
Time frame: 1-2 weeks
From date of randomization until the date of first documented progression
Cairo University
Other
Opioid Sparing Anesthesia Using Ketodex Versus Opioid Based Anesthesia in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy: A Randomized Controlled Trial.
Acronym: Ketodex
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