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The Effect of Opioid Free Anesthesia in Bariatric Surgeries (Opioidfree)

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ClinicalTrials.gov Identifier: NCT04048200
Recruitment Status : Completed
First Posted : August 7, 2019
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Sameh Abdelkhalik Ahmed Ismaiel, Tanta University

Tracking Information
First Submitted Date  ICMJE August 6, 2019
First Posted Date  ICMJE August 7, 2019
Last Update Posted Date June 18, 2020
Actual Study Start Date  ICMJE September 1, 2019
Actual Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
Postoperative opioid consumption [ Time Frame: The first 24 hours postoperatively ]
The total dose of morphine consumed postoperative as a rescue analgesia to maintain the VAS less than 4
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
Intraoperative sevoflurane consumption [ Time Frame: Through out the whole intraoperative period ]
The intraoperative consumption of sevoflurane in ml per one hour
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Opioid Free Anesthesia in Bariatric Surgeries
Official Title  ICMJE The Effect of Opioid Free Anesthesia on the Postoperative Opioid Consumption in Laparoscopic Bariatric Surgeries: Randomized Controlled Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Supportive Care
Condition  ICMJE
  • Adverse Effect of Drugs and Medicaments in Therapeutic Use
  • Adverse Effects in the Therapeutic Use of Anaesthetics
Intervention  ICMJE
  • Drug: Fentanyl
    Anesthesia will be induced by fentanyl, propofol, and rocuronium with maintenance of anesthesia using sevoflurane.
    Other Name: Opioid based Anesthesia
  • 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.
    Other Name: Opioid sparing
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Fentanyl
  • Experimental: 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.
    Intervention: Drug: Dexmedetomidine Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 15, 2020
Actual Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04048200
Other Study ID Numbers  ICMJE 33107/05/19
Tanta University ( Other Identifier: Faculty of Medicine, Tanta University )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Once the study had been successfully completed, the data will be shared for other researchers.
Responsible Party Sameh Abdelkhalik Ahmed Ismaiel, Tanta University
Study Sponsor  ICMJE Tanta University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sameh Ismaiel, M.D Lecturer of Anesthesia and Intensive Care, Tanta University
PRS Account Tanta University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP