The Effect of Opioid Free Anesthesia in Bariatric Surgeries

NCT ID: NCT04048200

Last Updated: 2020-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-06-15

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.

Detailed Description

This prospective randomized controlled study will be carried out on patients who will be presented for laparoscopic bariatric surgery in the general surgery department in Tanta university hospitals over six-month duration that will start immediately after obtaining ethical committee approval and clinical trial registration. An informed written consent will be obtained from all the participants, all patients data will be confidential and will be used for the current study only.

Inclusion criteria:

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.

Exclusion criteria:

• 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.

Anesthetic technique Once the patients will arrive to the operating room, intravascular access will be established, fluid preload will be started, and basic monitor will be attached.

The patients will be randomly distributed into two equal groups by the aid of computer-generated software of randomization: - ▪ Control group (30 patients): 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, 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.

▪ Opioid free anesthesia group (30 patients): 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. 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.

In both groups, routine anti-emetic prophylaxis will be administrated composed of ondansetron 4 mg and dexamethasone 8 mg before the surgery. Additional analgesia will be provided using 1 gm of paracetamol together with intraperitoneal local anesthetics and wound infiltration.

All the patients will be connected to the bispectral index monitor with maintaining its value 40-60. Increase in n bispectral index value above 60 will be managed by additional dose of fentanyl 0.5 ug/kg IBW and increasing the concentration of sevoflurane by 0.2% till the value decreased below 60.

At the end of the surgery, the inhalational anesthesia will be switched off with reversal of muscle relaxation using neostigmine and atropine with full awake extubation of the patient. The patients will be transported to the recovery room for adequate postoperative monitoring and management.

Measurements:

1. Patient age, weight, height.

2. The total dose consumption of fentanyl consumed intraopeartively.

3. The total volume consumed of sevoflureane intraoperatively (ml/hr).

4. The postoperative Visual Analogue Score (VAS): It will be measured every 2 hours till 6 h, then every 4 h till 24 h. In case of increase the VAS more than 3, a rescue analgesia will be administrated in the form of 2mg morphine i.v that may be repeated.

5. The time for the first request of morphine rescue analgesia

6. The total dose of morphine consumed in the first 24 h after surgery

7. The recovery profile of the patient.

8. Patients satisfaction.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Control group

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.

Group Type: OTHER

Fentanyl

Intervention Type: DRUG

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

Opioid free anesthesia group

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.

Group Type: EXPERIMENTAL

Dexmedetomidine Ketamine

Intervention Type: 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.

Interventions

Fentanyl

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

Intervention Type: DRUG

Dexmedetomidine Ketamine

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.

Intervention Type: DRUG

Other Intervention Names

Opioid based Anesthesia; Opioid sparing

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Sameh Abdelkhalik Ahmed Ismaiel

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sameh Ismaiel, M.D

Role: PRINCIPAL_INVESTIGATOR

Lecturer of Anesthesia and Intensive Care, Tanta University

Locations

Tanta University hospitals

Tanta, , Egypt

Countries

Egypt

Other Identifiers

Tanta University

Identifier Type: OTHER

Identifier Source: secondary_id

33107/05/19

Identifier Type: -

Identifier Source: org_study_id