Effect of Single Dose of Tramadol on Extubation Response and Quality of Emergence(Cough and Nausea Vomiting) Following Supratentorial Intracranial Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Haemodynamic Parameters at the Time of Emergence and Postextubation
研究概览
简要总结
Several modalities have been studied to prevent coughing during emergence, including extubation in a deep plane of anesthesia but have proved to be unreliable. So far, no reliable method is recommended as standard of care. The advantages of administering tramadol includes a long duration of action, rapid recovery, limited depression of respiratory function and no effect on platelet makes it a safe medication to use for neurosurgical patients after craniotomy. The primary objective of the study is to observe the effect of single dose of tramadol (1mg/kg) administered 45 minutes before extubation on hemodynamic response (measurement of B.P and H.R) during extubation.
详细描述
Extubation after intracranial tumor surgery is desirable in order to make an early diagnosis of intracranial complications. Extubation however, may be associated with haemodynamic and metabolic changes e.g. agitation, increased oxygen consumption, catecholamine secretion, hypercapnia and systemic hypertension.
These changes cause cerebral hyperemia, intracranial hypertension leading to cerebral oedema or haemorrhage, thus it is important to have smooth extubation with minimal haemodynamic and metabolic effects.
Incidence of coughing on emergence from general anesthesia ranges from 38% to 96%. This may also result in postoperative intracranial hemorrhage, intracranial hypertension, cerebral edema or intraocular hypertension.This can be detrimental in neurosurgery.
Several modalities have been studied to prevent coughing during emergence, including extubation in a deep plane of anesthesia but have proved to be unreliable. So far, no reliable method is recommended as standard of care.
Tramadol, a synthetic opioid of the aminocyclohexanes group, is a centrally acting opioid analgesic that is used to treat moderate-to-severe pain and has an inhibitory effect on M1 and M3 muscarinic receptors. It also reduces the incidence of cough and improves extubation quality, and provides more stable haemodynamics during emergence. It neither causes respiratory depression, nor affects intracranial pressure (ICP) and cerebral perfusion pressure (CPP). Other potential advantage of administering tramadol includes a long duration of action, rapid recovery, limited depression of respiratory function and no effect on platelets thus making it a safe medication to use for neurosurgical patients after craniotomy. The onset of effect following a single dose is 3 to 5 minutes with peak effect at 45 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Patients with craniotomy for supratentorial tumors under general anesthesia
- •American Society of Anaesthesiologists (ASA) 2 and stable ASA 3 patients
- •Elective surgery
- •Patients with Glasgow Coma Scale (GCS) 15/15
排除标准
- •Patients with a history of allergy or hypersensitivity to tramadol.
- •History of epilepsy or convulsions due to any reason.
- •Chronic usage of analgesic drugs.
- •Patients using monoamine oxidase inhibitors.
- •Patients with clinical signs of raised ICP.
- •Obesity (women with a body mass index >35 kg/m2 or men with a body mass index >42 kg/m2)
- •Language barrier.
- •Patients taking B-blockers or Ca channel blockers.
- •Patients above 65 years of age ( Physiology difference)
研究组 & 干预措施
Tramadol
Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg or (1ml/10kg) via intravenous route, once, at the time of dura closure
干预措施: Injection Tramadol (Drug)
Placebo
0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure
干预措施: placebo (Other)
结局指标
主要结局
Haemodynamic Parameters at the Time of Emergence and Postextubation
时间窗: Diastolic BP from the time of extubation till 6 hours post operatively
Diastolic blood pressure will be recorded at 1 minute before giving the reversal (glycopyrolate and neostigmine) and then 1,2,5,10,20,30 minutes ,1,2,4 and 6 hours after extubation. If values of blood pressure rise more than 20% from baseline values injection Metoprolol 1mg (beta blocker) bolus will be used and titrated according to response. The study will end at 6 hours post extubation.
次要结局
- Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale.(Cough at the time of emergence)
- Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Laryngospasm and Bronchospasm.(at the time of extubation till 6 hours postoperatively)
- Measure the Quality of Emergence From General Anaesthesia by Measuring Sedation Score(at the time of extubation till 6 hours postoperatively)
- Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV(at Recovery Room , 2, 4 and 6 hours postoperatively)
- Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions(at Recovery Room, 2, 4 and 6 hours postoperatively)
- Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS(at Recovery Room, 2, 4 and 6 hours postoperatively)
- Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia(At Recovery room, 2, 4 and 6 hours postoperatively)
- Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation(at the time of extubation)
研究者
Asma Abdus Salam
Senior Instructor
Aga Khan University