Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids

NARecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

January 1, 2023

Primary Completion Date

February 28, 2025

Study Completion Date

June 1, 2025

Conditions
Opioid Use, UnspecifiedBariatric Surgery Candidate
Interventions
DRUG

Opioid Free Anaesthesia

"* 40 mg/kg magnesium sulfate in 100 ml N/S infusion~* 0.4 mcg/kg dexmedetomidine, max total dose 50mcg in 50 ml N/S infusion~* 0.3 mg/kg ketamine in 10 ml volume~* 0.2 ml/kg of the Multimix regimen in 100 ml N/S infusion as a bolus (The Multimix regimen consists of 50mcg dexmedetomidine, 500 mg lidocaine and 50mg ketamine).~* 0.2 ml/kg/h of the Multimix regimen in 100 ml N/S infusion as a continuous infusion. Except for standard analgesic strategies, both groups will receive fentanyl as a rescue dose (1mcg/kg) based on a nociceptive level value \> 25 or elevation of Heart Rate and/or Blood Pressure \>20%.~Placebo infusions of normal saline will be prepared to enable blinding."

DRUG

Opioid based anesthesia

"* 2 mcg/kg fentanyl in 10 ml volume~* 0.2 mL/kg/h remifentanil infusion~* 0.1 mg/kg morphine. Except for standard analgesic strategies, both groups will receive fentanyl as a rescue dose (1mcg/kg) based on a nociceptive level value \> 25 or elevation of Heart Rate and/or Blood Pressure \>20%.~Placebo infusions of normal saline will be prepared to enable blinding."

Trial Locations (1)

11527

RECRUITING

G.Gennimatas General Hospital, Athens

All Listed Sponsors
collaborator

Aristotle University Of Thessaloniki

OTHER

lead

G.Gennimatas General Hospital

OTHER