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NCT Number: NCT05681429

Accelerated Recovery Following Opioid-free Anaesthesia in Supratentorial Craniotomy

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Malays Medical Centre

Kuala Lumpur, 50603, Malaysia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Group B

Primary outcomes

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

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

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

Secondary outcomes

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

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

    Time to Extubation in minutes , the shorter the duration of time, the better the recovery outcome

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

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

    Numerical Pain Score , minimum score: 0, maximum score: 10, the lower the pain score,the better the pain control

  3. 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.

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

    Time to first rescue of opioid analgesia (fentanyl) in minutes

  4. 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.

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

    Time to Modified Ramsay Sedation Score of 2 in minutes, the shorter the duration of time, the better the recovery outcome

  5. 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.

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

    Short Orientation Memory Concentration Test (SOMCT) score, minimum score: 0, maximum score: 28, the higher the score, the better the cognitive function

  6. To compare time to return of power of elbow flexion of dominant hand to 5 of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.

    Time frame: From time of arrival in peri anaesthesia care unit till time to return of power of elbow flexion of dominant hand to 5, up till 24 hours

    Time to return of Power of elbow flexion of dominant hand to 5 in minutes, the shorter the duration of time, the better the recovery of muscle power

  7. To compare modified Aldrete score of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.

    Time frame: From time of arrival in peri anaesthesia care unit till discharge from peri anaesthesia recovery unit, up till 24 hours

    Modified Aldrete score, minimum score: 0, maximum score: 10, the higher the score, the better the recovery

  8. To compare duration of stay in peri anaesthesia care unit (PACU) of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.

    Time frame: From the time of arrival in peri anaesthesia care unit till discharge from peri anaesthesia recovery unit, up till 24 hours

    Duration of stay in peri anaesthesia care unit (PACU) in minutes, the shorter the duration of stay, the better the recovery outcome

  9. To compare total postoperative opioid consumption of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.

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

    Total postoperative opioid consumption (in morphine equivalent- in milligram), the lower the opioid consumption, the better the pain control

  10. To compare incidence of postoperative nausea and vomiting (PONV) of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.

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

    Incidence of postoperative nausea and vomiting (PONV), yes or no

  11. To compare total length of hospital stay of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.

    Time frame: From the day of admission to hospital till the day of discharge from hospital, up till 365 days

    Length of hospital stay in days, the shorter the number of days of hospital stay, the better the recovery outcome

  12. To compare haemodynamic responses: Blood Pressure during intubation of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.

    Time frame: From start of induction of anaesthesia till end of intubation process

    Haemodynamics readings: Blood Pressure (mmHg)

  13. To compare haemodynamic responses: Heart Rate during intubation of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.

    Time frame: From start of induction of anaesthesia till end of intubation process

    Haemodynamics readings: Heart Rate (beats per minute)

  14. To compare haemodynamic responses: Mean Arterial Pressure during intubation of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.

    Time frame: From start of induction of anaesthesia till end of intubation process

    Haemodynamics readings: Mean Arterial Pressure (MAP) (mmHg)

  15. To compare haemodynamic responses : Blood Pressure during cranial pinning of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.

    Time frame: From start of cranial pinning till end of cranial pinning process

    Haemodynamics readings: Blood Pressure (mmHg)

  16. To compare haemodynamic responses: Heart Rate during cranial pinning of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.

    Time frame: From start of cranial pinning till end of cranial pinning process

    Haemodynamics readings: Heart Rate (beats per minute)

  17. To compare haemodynamic responses: Mean Arterial Pressure during cranial pinning of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.

    Time frame: From start of cranial pinning till end of cranial pinning process

    Haemodynamics readings: Mean Arterial Pressure (MAP) (mmHg)

  18. To compare haemodynamic responses: Blood Pressure during skin incision of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.

    Time frame: From start of skin incision till end of skin incision process

    Haemodynamics readings: Blood Pressure (mmHg)

  19. To compare haemodynamic responses : Heart Rate during skin incision of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.

    Time frame: From start of skin incision till end of skin incision process

    Haemodynamics readings: Heart Rate (beats per minute)

  20. To compare haemodynamic responses: Mean Arterial Pressure during skin incision of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.

    Time frame: From start of skin incision till end of skin incision process

    Haemodynamics readings: Mean Arterial Pressure (MAP) (mmHg)

  21. To compare the difference of qCon and qNox indexes using CONOX in patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.

    Time frame: From start of induction of anaesthesia till end of surgery

    qCON and qNOX readings from CONOX monitor, minimum value: 0, maximum value: 100, optimum value intraoperatively: 40-60, the higher the score, the more higher the level of alertness of patient

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Collaborators

  • Fresenius Kabi

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 12, 2023
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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