Opioid-Free AnaesthesiaNCT05681429
Accelerated Recovery Following Opioid-free Anaesthesia in Supratentorial Craniotomy
A study testing Lignocaine, Dexmedetomidine, Sevoflurane, Paracetamol, Parecoxib in people with Opioid-Free Anaesthesia, run by University of Malaya at 1 site in Malaysia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid-Free Anaesthesia
- What is being tested?
- Lignocaine, Dexmedetomidine, Sevoflurane, Paracetamol, Parecoxib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Lignocaine, Dexmedetomidine, Sevoflurane, Paracetamol, Parecoxib
- Keywords
- Opioid-free Anaesthesia, Supratentorial Craniotomy, Accelerated recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lignocaine, Dexmedetomidine, Sevoflurane, Paracetamol, ParecoxibDrug
Also called Group B
To compare the recovery outcome of patients who undergo supratentorial craniotomy with opioid-based anaesthesia and opioid-free anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Opioid-based Anaesthesia | Placebo comparator | This arm will be given drugs for standard opioid-based anaesthesia. Receives: 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) Receives: Drug: Lignocaine, Dexmedetomidine, Sevoflurane, Paracetamol, Parecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Time to Extubation in minutes , the shorter the duration of time, the better the recovery outcome
Measured: 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.
Numerical Pain Score , minimum score: 0, maximum score: 10, the lower the pain score,the better the pain control
Measured: 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.
Time to first rescue of opioid analgesia (fentanyl) in minutes
Measured: 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.
Time to Modified Ramsay Sedation Score of 2 in minutes, the shorter the duration of time, the better the recovery outcome
Measured: 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.
Short Orientation Memory Concentration Test (SOMCT) score, minimum score: 0, maximum score: 28, the higher the score, the better the cognitive function
Measured: From time of arrival in peri anaesthesia care unit till completion of Short Orientation Memory Concentration Test (SOMCT), up till 24 hours
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 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
Measured: 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
To compare modified Aldrete score of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.
Modified Aldrete score, minimum score: 0, maximum score: 10, the higher the score, the better the recovery
Measured: From time of arrival in peri anaesthesia care unit till discharge from peri anaesthesia recovery unit, up till 24 hours
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.
Duration of stay in peri anaesthesia care unit (PACU) in minutes, the shorter the duration of stay, the better the recovery outcome
Measured: From the time of arrival in peri anaesthesia care unit till discharge from peri anaesthesia recovery unit, up till 24 hours
To compare total postoperative opioid consumption of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.
Total postoperative opioid consumption (in morphine equivalent- in milligram), the lower the opioid consumption, the better the pain control
Measured: From the time of arrival in peri anaesthesia care unit till 24 hours post time of end of surgery
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.
Incidence of postoperative nausea and vomiting (PONV), yes or no
Measured: From the time of arrival in peri anaesthesia care unit till 24 hours post time of end of surgery
To compare total length of hospital stay of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.
Length of hospital stay in days, the shorter the number of days of hospital stay, the better the recovery outcome
Measured: From the day of admission to hospital till the day of discharge from hospital, up till 365 days
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.
Haemodynamics readings: Blood Pressure (mmHg)
Measured: From start of induction of anaesthesia till end of intubation process
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.
Haemodynamics readings: Heart Rate (beats per minute)
Measured: From start of induction of anaesthesia till end of intubation process
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.
Haemodynamics readings: Mean Arterial Pressure (MAP) (mmHg)
Measured: From start of induction of anaesthesia till end of intubation process
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.
Haemodynamics readings: Blood Pressure (mmHg)
Measured: From start of cranial pinning till end of cranial pinning process
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.
Haemodynamics readings: Heart Rate (beats per minute)
Measured: From start of cranial pinning till end of cranial pinning process
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.
Haemodynamics readings: Mean Arterial Pressure (MAP) (mmHg)
Measured: From start of cranial pinning till end of cranial pinning process
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.
Haemodynamics readings: Blood Pressure (mmHg)
Measured: From start of skin incision till end of skin incision process
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.
Haemodynamics readings: Heart Rate (beats per minute)
Measured: From start of skin incision till end of skin incision process
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.
Haemodynamics readings: Mean Arterial Pressure (MAP) (mmHg)
Measured: From start of skin incision till end of skin incision process
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.
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
Measured: From start of induction of anaesthesia till end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start1 Jan 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Free AnaesthesiaStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blinded prospective randomised controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Kabi
- Responsible party
- Principal investigator, Dr. Chu Mei Yeen, University of Malaya
- Investigators
- Dr Jeyaganesh a/l S. Veerakumaran, Study chair, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681429
- Sponsor's protocol ID
- 2022724-11404
- Status last verified
- Apr 2024
- First submitted
- 6 Dec 2022
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Research data WITHOUT participants' personal information and identifier will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Recovery Following Opioid-free Anaesthesia in Supratentorial Craniotomy
- ClinicalTrials.gov ID
- NCT05681429
- Acronym / sponsor ID
- 2022724-11404
- Conditions
- Opioid-Free Anaesthesia
- Keywords
- Opioid-free Anaesthesia, Supratentorial Craniotomy, Accelerated recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Collaborators
- Fresenius Kabi
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-blinded prospective randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Opioid-based Anaesthesia | Placebo comparator | Drug: Lignocaine, Dexmedetomidine, Sevoflurane, Paracetamol, ParecoxibThis arm will be given drugs for standard opioid-based anaesthesia. |
| Opioid-free Anaesthesia | Experimental | Drug: Lignocaine, Dexmedetomidine, Sevoflurane, Paracetamol, ParecoxibThis 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lignocaine, Dexmedetomidine, Sevoflurane, Paracetamol, ParecoxibAlso: Group BTo compare the recovery outcome of patients who undergo supratentorial craniotomy with opioid-based anaesthesia and opioid-free anaesthesia | Drug | Opioid-based Anaesthesia, Opioid-free Anaesthesia |
Primary outcome
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
21 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: Yes. Research data WITHOUT participants' personal information and identifier will be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Jeyaganesh a/l S. Veerakumaran study chair
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lignocaine, Dexmedetomidine, Sevoflurane, Paracetamol, Parecoxib in people with Opioid-Free Anaesthesia, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.