Opioid Free Anesthesia in Obese Patients.

Opioid Free Anesthesia for Upper Limb Surgery in Obese Patients.

Using opioids in the clinical practice of anesthesia was astonishing. They are good analgesics and used widely to modulate perioperative pain, but analgesia with these drugs can be associated with many side effects that may lead to prolongation of hospital stay and recovery period like respiratory depression, delirium, impaired gastrointestinal function, urine retention, post-operative nausea and vomiting (PONV), and addiction. The most significant opioid side effect is respiratory depression. This is especially important in patients suffering from obesity. Obese patients already have a restrictive lung disease leading to decrease in functional residual capacity and total lung compliance. Anesthetics and analgesics specially opioids make these respiratory problems become worse with increasing the incidence of hypoxia. These side effects can be avoided by using opioid free anesthesia (OFA) techniques.

Opioid free anesthesia recently become more applicable and popular in different centers, it provides pain control with marked reduction in opioid consumption. However, researches and studies still unable to explore definite explanations or techniques regarding it. The base of OFA is that not only one drug can replace opioids. It is a multimodal anesthesia. Multiple drugs are used to achieve it. They are hypnotics,N-methyl-D-aspartate (NMDA) antagonists (ketamine, magnesium sulfate), sodium channel blockers (local anesthetics), anti-inflammatory drugs (NSAID, dexamethasone), and alpha-2 agonists (dexmedetomidine, clonidine). Regional anesthesia and nerve blocks also have a role. In this study, using OFA the investigators are hoping to achieve a good quality of care to obese patients helping in fast track surgery with less complications and so shorter period of hospital stay

Study Overview

• Status: Completed
• Conditions: Opioid Free Anesthesia
• Intervention / Treatment: Drug: dexmedetomidine,ketamine,lidocaine,propofol; Drug: fentanyl,propofol

Detailed Description

Patients will be randomly allocated (by closed envelope method) to two groups:

Group A (n=38) will have opioid free anesthesia (OFA) Group B (n=38) will have opioid based anesthesia (OPA) All patients will be subjected to a preoperative clinical examination and routine preoperative laboratory investigations. Patients also will be trained on how to deal with the VAS score before surgery. The visual analog scale (VAS) is a pain score using a 10-cm line with two ends "no pain" on the left end and the "worst pain" on the right end, used to track pain for a patient or to compare pain between patients.(9,10) In the operating room (OR), peripheral oxygen saturation (spo2), noninvasive blood pressure and electrocardiogram ( ECG) will be monitored and recorded as a baseline reading. A peripheral intravenous cannula will be inserted t hen patients in both groups will receive 1mg of midazolam prior induction of anesthesia. Preoxygenation 3-5 minutes before induction will be done. Group (A): Induction of general anesthesia will be done using lidocaine (1.5 mg/kg), propofol (2-3 mg/kg), and atracurium (0.5 mg/kg). Dexmedetomidine 0.5 µg/kg over 10 min, started 10 min before induction. Following tracheal intubation, dexmedetomidine infusion generally will be initiated at 0.6 μg/kg/h and titrated between 0.2 and 1.0 μg/kg/h according to the heart rate maintaining bispectral index (BIS) between 40-60, lidocaine (1.5 mg/kg/h). ketamine will be given as a bolus dose of 0.3 mg/kg after induction and prior to skin incision then 0.2 mg/kg/h as an infusion. Patients will receive dexamethasone (8 mg i.v.) after induction. In group (B) for induction of anesthesia, patients will receive propofol 2-3mg/kg, fentanyl 1-2mcg/kg and atracurium 0.5 mg/kg as a muscle relaxant to facilitate intubation. Fentanyl bolus doses of 0.5-1 mcg/kg will be given to keep BIS score 40-60 during surgery.

All Patients will be mechanically ventilated with 50% O2 and 50% air and the end-tidal carbon dioxide( CO2) will be maintained between 30 - 35 mmHg. Anesthesia will be maintained by isoflurane and atracurium 0.1-0.2 mg/kg every 20-30 minutes. Reversal of muscle relaxants will done by using intravenous neostigmine (0.05 mg/kg) and atropine (0.01 mg/kg) at the end of surgery and the patient will be extubated when the patient will be able to breath spontaneously with tidal volume ≥5ml/kg and spo2>92%. Paracetamol 1gm i.v. infusion and ketorolac 30 mg slow i.v injection will be used at the end of surgery and before emergence in both groups. At the recovery room, patients will assess their pain and rating it using VAS score, monitored for postoperative pain, the patients will leave the post anesthesia care unit (PACU) with Aldrete score more than 9. (11) Any patient with Vas score ≥4, will receive tramadol 1mg/kg i.v. with a maximum dose 600mg/day.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rana A Abdelghaffar, MD; Phone Number: +20 01002360634; Email: rona0022@yahoo.com

Study Locations

• Egypt
  • Fayoum, Egypt, 63514
    • Fayoum university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• American Society of Anesthesiologist (ASA) physical status Ⅱ , Ⅲ.
• body mass index (BMI) ≥30 kg/m2.
• Have upper limb surgeries (orthopedics, plastic,…) under general anesthesia.

Exclusion Criteria:

• Known allergy to the drugs will be used in the study.
• Pregnancy and lactation.
• Addiction or recent use of opioids'
• Patients will not be able deal with visual analog score(VAS).
• Hepatic, Renal and cardiac diseases in advanced stages.
• History of epilepsy or seizures.
• Patients with cerebrovascular disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexmedetomidine group; Group A , Induction of general anesthesia will be done using lidocaine (1.5 mg/kg), propofol (2-3 mg/kg), and atracurium (0.5 mg/kg). Dexmedetomidine 0.5 µg/kg over 10 min, started 10 min before induction. Following tracheal intubation, dexmedetomidine infusion generally will be initiated at 0.6 μg/kg/h and titrated between 0.2 and 1.0 μg/kg/h according to the heart rate maintaining bispectral index (BIS) between 40-60, lidocaine (1.5 mg/kg/h). ketamine will be given as a bolus dose of 0.3 mg/kg after induction and prior to skin incision then 0.2 mg/kg/h as an infusion. Patients will receive dexamethasone (8 mg i.v.) after induction.	Drug: dexmedetomidine,ketamine,lidocaine,propofol; Group (A): Induction of general anesthesia will be done using lidocaine (1.5 mg/kg), propofol (2-3 mg/kg), and atracurium (0.5 mg/kg). Dexmedetomidine 0.5 µg/kg over 10 min, started 10 min before induction. Following tracheal intubation, dexmedetomidine infusion generally will be initiated at 0.6 μg/kg/h and titrated between 0.2 and 1.0 μg/kg/h according to the heart rate maintaining bispectral index (BIS) between 40-60, lidocaine (1.5 mg/kg/h). ketamine will be given as a bolus dose of 0.3 mg/kg after induction and prior to skin incision then 0.2 mg/kg/h as an infusion. Patients will receive dexamethasone (8 mg i.v.) after induction.; Other Names: dexamethasone
Placebo Comparator: Opioid group; In group (B) (OBA) for induction of anesthesia, patients will receive propofol 2-3mg/kg, fentanyl 1-2mcg/kg and atracurium 0.5 mg/kg as a muscle relaxant to facilitate intubation. Fentanyl bolus doses of 0.5-1 mcg/kg will be given to keep BIS score 40-60 during surgery.	Drug: fentanyl,propofol; In group (B) for induction of anesthesia, patients will receive propofol 2-3mg/kg, fentanyl 1-2mcg/kg and atracurium 0.5 mg/kg as a muscle relaxant to facilitate intubation. Fentanyl bolus doses of 0.5-1 mcg/kg will be given to keep BIS score 40-60 during surgery.; Other Names: fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attacks of postoperative pain with vas score ≥4	The visual analog scale (VAS) is a pain score using a 10-cm line with two ends "no pain" on the left end and the "worst pain" on the right end, postoperative pain with vas score ≥4 will be monitored and recorded	24 hours postoperative
rescue doses of tramadol	time of rescue doses of tramadol	24 hours postoperative
how many rescue doses of tramadol	number of rescue doses of tramadol	24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoxia	number of patients with hypoxia (an Spo2 level of less than 95%)	every 2hours for 24 hours.
Postoperative nausea and vomiting.	Postoperative nausea and vomiting( number of attacks)	24 hours postoperative
Postoperative usage of antiemetics	number of patients who will need rescue dose of antiemetic medication.	24 hours postoperative
Intraoperative bradycardia	number of patients who will develop intra-operative bradycardia HR≤50bpm,	intraoperative
Intraoperative hypotension	number of patients who will develop intra-operative hypotension mean arterial blood pressure ( mABP) ≤60 millimetre of mercury (mmHg)	intraoperative
Intraoperative hypertension	number of patients who will develop intra-operative hypertension mABP ≥90mmHg).	intraoperative
ICU admission.	number of participants who will need intensive care unit	24 hours postoperative
extubation time	time when endotracheal tube removed from the patients	60 minutes after cessation of anesthesia

Collaborators and Investigators

• Sponsor: Fayoum University Hospital
• Investigators: Principal Investigator: Rana A Abelghaffar, MD, Faculty of medicine , Fayoum university

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): August 14, 2023
• Study Completion (Actual): November 5, 2023

Study Registration Dates

• First Submitted: July 20, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: dexmedetomidine; ketamine; obese; opioid free anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Ketamine; Dexamethasone; Fentanyl; Propofol; Dexmedetomidine; Lidocaine
• Other Study ID Numbers: opioid free anesthesia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No