Accelerated Recovery Following Opioid-free Anaesthesia in Supratentorial Craniotomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- To compare sedation score of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Single-blinded RCT
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Opioid-based Anaesthesia
This arm will be given drugs for standard opioid-based anaesthesia.
干预措施: Lignocaine, Dexmedetomidine, Sevoflurane, Paracetamol, Parecoxib (Drug)
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)
干预措施: Lignocaine, Dexmedetomidine, Sevoflurane, Paracetamol, Parecoxib (Drug)
结局指标
主要结局
To compare sedation score of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.
时间窗: 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
次要结局
- 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 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 total length of hospital stay of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.(From the day of admission to hospital till the day of discharge from hospital, up till 365 days)
- 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)
- 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.(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.(From the time of arrival in peri anaesthesia care unit till 24 hours post time of end of surgery)
- 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.(From start of cranial pinning till end of cranial pinning 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.(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.(From start of skin incision till end of skin incision process)
- 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 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.(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 haemodynamic responses: Mean Arterial Pressure during intubation of patients who undergo elective supratentorial craniotomies with opioid-free anaesthesia and those with opioid-based anaesthesia.(From start of induction of anaesthesia till end of intubation 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.(From start of skin incision till end of skin incision process)
- To compare modified Aldrete 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 discharge from peri anaesthesia recovery unit, up till 24 hours)
- 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.(From start of induction of anaesthesia till end of intubation process)
- 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 incidence of postoperative nausea and vomiting (PONV) 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)
- 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.(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.(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.(From start of cranial pinning till end of cranial pinning 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.(From start of induction of anaesthesia till end of surgery)
研究者
Dr. Chu Mei Yeen
Principal Investigator, Trainee in Master of Anaesthesiology & Intensive Care
University of Malaya