The Effect of Opioid Free Anesthesia in Bariatric Surgeries

NCT04048200 | Completed Phase 4

• 2 other identifiers: 33107/05/19Tanta University
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomized controlled study that will be carried out on morbid obese patients admitted to Tanta University hospitals for laparoscopic bariatric surgeries. The patients will be randomly assigned into;- Control group:- Anesthesia will be induced by fentanyl 1 ug/kg, propofol 2 mg/kg, and rocuronium 1 mg/kg to facilitate tracheal intubation. Anesthesia will be maintained by sevoflurane 2% in a mixture of oxygen: Air 1: 1 to maintain entropy 40-60. Opioid free anesthesia group;- Anesthesia will be induced by propofol 2 mg/kg, rocuronium 1 mg/kg to facilitate tracheal intubation. After endotracheal intubation, and a combination of dexmedetomidine and ketamine infusion. Anesthesia will be maintained by sevoflurane 2% in a mixture of oxygen: Air 1: 1 and continuing the infusion of dexmedetomidine and ketamine o maintain entropy 40-60.

Conditions

Adverse Effect of Drugs and Medicaments in Therapeutic Use; Adverse Effects in the Therapeutic Use of Anaesthetics

Keywords

Dexmedetomidine; Ketamine; Fentanyl; Bariatric surgeries

Outcome Measures

Primary Outcomes (1)

• Postoperative opioid consumption

  The total dose of morphine consumed postoperative as a rescue analgesia to maintain the VAS less than 4

  The first 24 hours postoperatively

Secondary Outcomes (1)

• Intraoperative sevoflurane consumption

  Through out the whole intraoperative period

Study Arms (2)

Control group

OTHER

Anesthesia will be induced by fentanyl 1 ug/kg, propofol 2 mg/kg, and rocuronium 1 mg/kg to facilitate tracheal intubation. After endotracheal intubation, the patients will be connected to mechanical ventilator with its parameters adjusted to maint5ain etCO2 32-36 mmhg. Anesthesia will be maintained by sevoflurane 2% in a mixture of oxygen: Air 1: 1 to maintain entropy 40-60. The patients in this group will be connected to a syringe pump before induction of anesthesia that was prepared by anesthesia resident not participating in the study and contain normal saline and adjusted at a rate of 1 ml/kg/hr till the end of the surgery.

Drug: Fentanyl

Opioid free anesthesia group

EXPERIMENTAL

A syringe 50 ml was prepared by anesthesia resident not participating in the study and contain 100 ug of dexmedetomidine (2 ug/ml) and 25 mg ketamine 90.5 mg/ml) and 200 mg lidocaine (4 mg/ml). The syringe will be connected to the patients before induction of anesthesia at a rate of 0.1 ml/kg/hr according to the ideal body weight. Anesthesia will be induced by propofol 2 mg/kg, and rocuronium 1 mg/kg to facilitate tracheal intubation. After endotracheal intubation, the patients will be connected to mechanical ventilator with its parameters adjusted to maint5ain etCO2 32-36 mmhg. Anesthesia will be maintained by sevoflurane 2% in a mixture of oxygen: Air 1: 1 to maintain entropy 40-60. The syringe infusion will be continued till the end of peritoneal manipulation. Patients in this group will receive magnesium sulphate preload at a dose of 40 mg/kg ideal body weight followed by maintenance infusion of 10 mg/kg/hr.

Drug: Dexmedetomidine Ketamine

Interventions

Fentanyl DRUG

Anesthesia will be induced by fentanyl, propofol, and rocuronium with maintenance of anesthesia using sevoflurane.

Also known as: Opioid based Anesthesia

Control group

Dexmedetomidine Ketamine DRUG

No opioid will be used in induction of anesthesia. A combination of dexmedetomidine and ketamine will be infused. Sevoflurane will be used for maintenance of anesthesia.

Also known as: Opioid sparing

Opioid free anesthesia group

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Morbid obese patients with BMI 40-50 kg/m2
• Aged more than 21 years and American Society of Anesthesiologists Class III
• Presented for laparoscopic sleeve gastrectomy or gastric bypass.

You may not qualify if:

• Patients refused to participate.
• Patients with known or suspected or known allergy to the used medication.
• Patients with moderate to severe obstructive sleep apnea
• Patients with uncontrolled blood sugar, cardiac, renal, or hepatic functions.
• Patients receiving opioids preoperatively
• Uncooperative patients
• Patients received preoperative gabapentoids.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University hospitals

Tanta, 31511, Egypt

Location

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sameh Ismaiel, M.D

  Lecturer of Anesthesia and Intensive Care, Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded study Closed sealed envelops will be used to make the participants blind to their group. The continuous infusion regimen in the syringe pump will be prepared by anesthesia resident who will not participating in the the study . It will contain normal saline in control group and actual dexmedetomidine and ketamine in the other group. This will make the investigator blind to the group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Prospective study

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 7, 2019
• Study Start: September 1, 2019
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: June 18, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)