Clinical trial

Accelerated Recovery Following Opioid-free Anaesthesia in Supratentorial Craniotomy

Name
2022724-11404
Description
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.
Trial arms
Trial start
2023-01-01
Estimated PCD
2024-01-31
Trial end
2024-01-31
Status
Completed
Treatment
Lignocaine, Dexmedetomidine, Sevoflurane, Paracetamol, Parecoxib
To compare the recovery outcome of patients who undergo supratentorial craniotomy with opioid-based anaesthesia and opioid-free anaesthesia
Arms:
Opioid-based Anaesthesia, Opioid-free Anaesthesia
Other names:
Group B
Size
25
Primary endpoint
To compare sedation score of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.
From the time of arrival in peri anaesthesia care unit till 24 hours post time of end of surgery
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-blinded prospective randomised controlled trial', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Single-blinded RCT', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 25, 'type': 'ACTUAL'}}
Updated at
2024-04-09

1 organization

1 product

1 indication

Product
Lignocaine