Comparison of the Quality of Recovery of patients undergoing elective Supratentorial craniotomy -Total Intravenous Anesthesia with propofol versus Balanced Anesthesia with Sevoflurane – A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1.Quality of Recovery as assessed by the QoR-40 Questionnaire
研究概览
简要总结
Craniotomies have ahigher rate of postoperative complications than the general surgical population and adversely affects thequality of life. Moreover, patients undergoing craniotomy develop postoperativecognitive and physical deficits which makes it difficult to assess thepostoperative quality of recovery.
With the advancesin imaging and surgical techniques, the focus has shifted from merelyeliminating pathology to ensuring maximal functional recovery as early aspossible. Hence anesthetic techniques in addition to providing favorableintraoperative hemodynamics and brain relaxation must ensure a good quality of recoveryto the patient as perceived by the patient.
Quality of recovery- 40 is one of the tools which helps us assess the quality of recoverypostoperatively. QoR-40 questionnaireprobes into 5different aspects of health: physical comfort, physical independence, emotionalstate, psychological support, and pain. The validity, reliability, ease of use,and responsiveness of the QoR-40 have been confirmed in the neurosurgicalpopulation in previous studies.
In the practice ofneuroanaesthesia, intravenous anesthesia with propofol and remifentanil hasbeen preferred to inhalational anesthesia in terms of brain relaxationspecifically in patients with raised intracranial pressure as it is known to lower subduralintracranial pressure, provide highercerebral perfusion pressure, and less pronounced cerebral swelling.
However,a comparison between intravenous and inhalational anesthesia for supratentorialcraniotomy reveals that despite minimal differences, the short-term outcome interms of hemodynamic stability and intraoperative brain relaxation is notaffected in patients with normal intracranial pressure and both techniques arewidely in use.
Citerio et al in their recentmulticenter, randomized trial evaluating the equivalence of inhalational andintravenous anesthetic agents during craniotomy showed that the nearlypostoperative recovery, intraoperative hemodynamics, brain relaxation weresimilar in the 2 groups and both techniques are acceptable for craniotomies.
Studies done in thegeneral surgical population have demonstrated that TIVA with propofol providesa better quality of recovery as compared to Balanced General anesthesia. However, there are no studies that havecompared the quality of recovery with the 2 anesthetic techniques in theneurosurgical population.
We hypothesize that BalancedGeneral Anaesthesia with Sevoflurane provides similar postoperative quality ofrecovery as compared to the use of TIVA with propofol and Fentanyl in patientsundergoing supratentorial on the 1 st and 3 rd postoperative day (assessed bythe QoR-40 questionnaire) in patients with tumors presenting for electivesupratentorial craniotomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Age 18-65years 2.Supratentorial tumor with no significant clinical or radiological features of raised ICP and midline shift <1 cm.
排除标准
- •1.Emergency Procedure 2.Severe cardiovascular or respiratory disease (ASA grade ≥3), 3.Pregnancy 4.Allergies to Propofol 5.History of Renal, Liver disease 6.Psychiatric illnesses 7.Patient refusal 8.Awake Craniotomy 9.GCS<15, Preoperative Cognitive defects/Vision Loss, Symptomatic Raised Intracranial Pressure with hypertension and Bradycardia.
结局指标
主要结局
1.Quality of Recovery as assessed by the QoR-40 Questionnaire
时间窗: - To assess the quality of recovery using the QoR-40 scale on the Preoperative day 1 and 3 in neuro Ward or NICU.
次要结局
- 1.Intraoperative Haemodynamic Profile.
- 2.Brain Relaxation(assessed intraoperative by the surgeon and graded as per the brain relaxation score.)
- 3.Postoperative Recovery Profile(- Emergence time, Extubation time , skin incision to skin closure time , time from induction to time of discontinuation of anesthetics will be recorded.)
- 4.Postoperative Analgesia(-VAS will be recorded at, 30 min, 1 h, 2, 4, 6, 12, 18, 24,48,72 h post-surgery.)
