Accelerated Recovery Following Opioid-free Anaesthesia in Supratentorial Craniotomy

NCT ID: NCT05681429

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-01-31

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.

Detailed Description

Anaesthesia for craniotomy surgery focuses on maintaining cerebral perfusion, avoiding factors that may lead to increased intracranial pressure and aim for early postoperative neurological recovery. In recent decades, opioids have always been a mainstay for perioperative pain management and play an important role as the standard of care - opioid-based anaesthesia (OBA). However, opioid use poses a significant number of adverse effects such as respiratory depression, prolonged sedation, postoperative nausea and vomiting (PONV), pruritus, ileus, urinary retention, and hyperalgesia. This should be avoided in patients who undergo craniotomy as they can lead to an inaccurate neurological examination because of excessive sedation and have the potential to mask early signs of intracranial complications. Besides, opioid-induced respiratory depressions cause hypercapnia which increases cerebral blood flow and may lead to cerebral oedema. Opioid-induced PONV leads to a spike in intracranial pressure which can be detrimental for post-craniotomy patients. Despite this, adequate pain management is vital as suboptimal pain control drives sympathetic efflux, promoting hypertension that may increase morbidity and mortality through intracranial haemorrhage. 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 post-craniotomy. Multi-modal analgesia is also incorporated in many practices nowadays to achieve optimal intraoperative and post-craniotomy pain control. 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 might be used intraoperatively to measure hypnotic effect (qCon) and probability of response to noxious stimulus (qNox).

This prospective randomised controlled trial 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 to compare intraoperative and postoperative outcomes of patients who undergo elective supratentorial craniotomy with opioid-free anaesthesia (OFA) and those with opioid-based anaesthesia (OBA).

Conditions

Opioid-Free Anaesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Opioid-based Anaesthesia

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

Group Type: PLACEBO_COMPARATOR

Lignocaine, Dexmedetomidine, Sevoflurane, Paracetamol, Parecoxib

Intervention Type: DRUG

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

Opioid-free Anaesthesia

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)

Group Type: EXPERIMENTAL

Lignocaine, Dexmedetomidine, Sevoflurane, Paracetamol, Parecoxib

Intervention Type: DRUG

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

Interventions

Lignocaine, Dexmedetomidine, Sevoflurane, Paracetamol, Parecoxib

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

Intervention Type: DRUG

Other Intervention Names

Group B

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fresenius Kabi

INDUSTRY

Sponsor Role: collaborator

University of Malaya

OTHER

Sponsor Role: lead

Responsible Party

Dr. Chu Mei Yeen

Principal Investigator, Trainee in Master of Anaesthesiology & Intensive Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr Jeyaganesh a/l S. Veerakumaran

Role: STUDY_CHAIR

University of Malaya

Locations

Universiti Malays Medical Centre

Kuala Lumpur, , Malaysia

Countries

Malaysia

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

2022724-11404

Identifier Type: -

Identifier Source: org_study_id