Opioid Free Anesthesia in Obese Patients.

NCT05481970 | Completed

• 1 other identifier: opioid free anesthesia
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Opioid Free Anesthesia

Keywords

opioid free anesthesia; obese; dexmedetomidine; ketamine

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Hypoxia

  every 2hours for 24 hours.

• Postoperative nausea and vomiting.

  24 hours postoperative

• Postoperative usage of antiemetics

  24 hours postoperative

• Intraoperative bradycardia

  intraoperative

• Intraoperative hypotension

  intraoperative

Study Arms (2)

Dexmedetomidine group

ACTIVE COMPARATOR

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

Opioid group

PLACEBO COMPARATOR

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

Interventions

dexmedetomidine,ketamine,lidocaine,propofol DRUG

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.

Also known as: dexamethasone

Dexmedetomidine group

fentanyl,propofol DRUG

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.

Also known as: fentanyl

Opioid group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University

Al Fayyum, 63514, Egypt

Location

MeSH Terms

Conditions

Obesity

Interventions

Dexmedetomidine; Dexamethasone; Fentanyl; Propofol

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Piperidines; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Rana A Abelghaffar, MD

  Faculty of medicine , Fayoum university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesiology

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: August 1, 2022
• Study Start: September 1, 2022
• Primary Completion: August 14, 2023
• Study Completion: November 5, 2023
• Last Updated: February 20, 2024

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)