Accelerated Recovery Following Opioid-free Anaesthesia in Supratentorial Craniotomy

NCT05681429 | Completed

• 1 other identifier: 2022724-11404
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Anaesthesia for craniotomy (open skull/brain) surgery focuses on maintaining blood supply to brain, avoiding factors that may lead to increased pressure in brain and aim for early neurological recovery. In recent decades, opioids have always been a mainstay for pain management and opioid-based anaesthesia (OBA). However, opioid use poses a significant number of adverse effects such as breathing depression, prolonged sedation, nausea and vomiting, itchiness, and many more. In view of this, recent studies on anaesthesia for craniotomy has noted a paradigm shift towards opioid-sparing or opioid-free anaesthesia (OFA) to prevent opioid-related adverse effects which might prolong patients' recovery. In order to guide anaesthesiologists' dosing of hypnotics and analgesics to provide appropriate depth of anaesthesia and adequate pain control, as well as to prevent under or overdosing, CONOX monitor is used during operation to measure depth of anaesthesia and painful stimulus. This clinical study will take place in neurosurgical operation theatres and neurosurgical intensive care unit (ICU) of University of Malaya Medical Centre (UMMC), Kuala Lumpur, Malaysia.

Conditions

Opioid-Free Anaesthesia

Keywords

Opioid-free Anaesthesia; Supratentorial Craniotomy; Accelerated recovery

Outcome Measures

Primary Outcomes (1)

• To compare sedation score of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.

  Modified Ramsay Sedation Score, minimum score: 1, maximum score: 8, the lower the score, the better the conscious level

  From the time of arrival in peri anaesthesia care unit till 24 hours post time of end of surgery

Secondary Outcomes (21)

• To compare time to extubation of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.

  From time of cessation of anaesthetic agents (remifentanil/sevoflurane/dexmedetomidine) till time of removal of endotracheal tube, up till 24 hours

• To compare pain score of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.

  From time of arrival in peri anaesthesia care unit till 24 hours post time of end of surgery

• To compare time to first rescue of opioid analgesia of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.

  From time of arrival in peri anaesthesia care unit till time to first recuse opioid analgesia is administered, up till 24 hours

• To compare time to Modified Ramsay Sedation Score of 2 of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.

  From time of arrival in peri anaesthesia care unit till Modified Ramsay Sedation Score of 2, up till 24 hours

• To compare Short Orientation Memory Concentration Test (SOMCT) score of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.

  From time of arrival in peri anaesthesia care unit till completion of Short Orientation Memory Concentration Test (SOMCT), up till 24 hours

Study Arms (2)

Opioid-based Anaesthesia

PLACEBO COMPARATOR

This arm will be given drugs for standard opioid-based anaesthesia.

Drug: Lignocaine, Dexmedetomidine, Sevoflurane, Paracetamol, Parecoxib

Opioid-free Anaesthesia

EXPERIMENTAL

This experimental arm will be given drugs for opioid-free anaesthesia as stated below to replace opioids used: Intravenous (IV) Lignocaine (1.5 mg/kg) Intravenous Infusion (IVI) Dexmedetomidine (0.2-0.7 mcg/kg/h) \& volatile (sevoflurane) \~ Minimum Alveolar Concentration (MAC) 0.9-1.0 IV Paracetamol 1 gm (give after scalp block) IV Parecoxib 40 mg (give 30 minutes before end of surgery) IV Ondansetron 4 mg (give 30 minutes before end of surgery) IV Metoclopramide 10 mg (rescue)

Drug: Lignocaine, Dexmedetomidine, Sevoflurane, Paracetamol, Parecoxib

Interventions

Lignocaine, Dexmedetomidine, Sevoflurane, Paracetamol, Parecoxib DRUG

To compare the recovery outcome of patients who undergo supratentorial craniotomy with opioid-based anaesthesia and opioid-free anaesthesia

Also known as: Group B

Opioid-based Anaesthesia; Opioid-free Anaesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients who have supratentorial lesions going for elective craniotomies (age group- 18-65 years old)
• Patients with Glasgow Coma Scale of 15 (E4V5M6)
• Patients who are fit to give consent
• Power of elbow flexion of patient's dominant hand score 5 with Medical Research Council (MRC) Muscle scale
• American Society of Anaesthesiologists (ASA) Physical Status Classification I - III patients

You may not qualify if:

• Patients who refused or not fit to consent for participation
• Patients with Glasgow Coma Scale less than 15
• Patients who have known allergy to the drugs used in this study
• Patients on chronic opioid use (Chronic opioid use is defined as having any number of opioid prescriptions or dosing for at least 90 days continuously)
• Patients going for emergency craniotomies for supratentorial lesions
• Patients who are not fit for extubation postoperatively
• Patients with chronic kidney disease Stage 3A and above (eGFR less than 60 ml/min/1.73m2)
• Patients with known case of liver cirrhosis

Sponsors & Collaborators

• University of Malaya: lead
• Fresenius Kabi: collaborator

Study Sites (1)

Universiti Malays Medical Centre

Kuala Lumpur, 50603, Malaysia

Location

MeSH Terms

Interventions

Lidocaine; Dexmedetomidine; Sevoflurane; Acetaminophen; parecoxib

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Dr Jeyaganesh a/l S. Veerakumaran

  University of Malaya

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blinded RCT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Trainee in Master of Anaesthesiology & Intensive Care

Model Details: Single-blinded prospective randomised controlled trial

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: January 12, 2023
• Study Start: January 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Dec 2023 till Dec 2024
• Access Criteria: Research data WITHOUT participants' personal information and identifier will be shared with other researchers

Locations

MY (1)