Comparing Deep Neuromuscular Block and Moderate Neuromuscular Block in Patients Undergoing Laparoscopic Gynaecological Surgeries: Impact on Surgical Satisfaction of Operating Conditions and Patient Satisfaction
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 主要终点
- Deep block versus Moderate block: Impact on surgical satisfaction
研究概览
简要总结
This study compares surgeon's satisfaction of operating conditions and patient's satisfaction following laparoscopic gynecological surgeries in two groups of patients, half of whom will receive deep neuromuscular blockade and the other half, moderate neuromuscular blockade.
详细描述
Deep neuromuscular blockade in anesthesia has been shown to improve operating conditions in retroperitoneal surgeries, while there is minimal evidence regarding this method in laparoscopic gynecological procedures.The advantage of improving surgical conditions with a deep neuromuscular blockade in laparoscopic surgery may however lead to a delayed neuromuscular recovery and hence a delay in turnover of patients.
Rocuronium will be used for muscle relaxation in order to achieve the necessary depth of neuromuscular blockade. Sugammadex is a modified cyclodextrin that forms complexes with rocuronium, reducing free plasma concentrations of rocuronium and reversing its neuromuscular blocking action from any depth.
The use of rocuronium will therefore aid in achieving a deep neuromuscular blockade which the investigators postulate will improve surgical conditions and the reversal with sugammadex will ensure a rapid recovery thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients identified from the anaesthetic clinic scheduled to undergo a laparoscopic gynaecological procedure under general anaesthesia
- •requiring tracheal intubation
- •elective surgeries (eg. laparoscopy & dye insufflation, bilateral tubal ligation, cystectomy, myomectomy, hysterectomy, salpingo-oophorectomy)
- •American Society of Anaesthesiology (ASA) I-II
排除标准
- •Anticipated difficult airway
- •Patients requiring rapid sequence induction
- •Patient anticipated to require admission to the intensive care unit (ICU) or not planned for extubation
- •Patient with liver or renal failure (creatinine clearance <50mls/min)
- •Patients with a baseline heart rate <50/min
- •Patients with documented or suspected neuromuscular disorder
- •Guillain - Barre syndrome
- •Cerebrovascular accidents with residual neurology
- •Parkinson's Disease
- •Myasthenia Gravis
- •Any condition making the administration of patient satisfaction questionnaire difficult/impossible
- •speech or hearing impairment and language barriers
- •Patients on fusidic acid or toremifene 24 hours before surgery
- •Patients on hormonal contraceptives; oral or otherwise
- •Patients on drugs, medical problems that may prolong or shorten the duration of rocuronium- (eg.. aminoglycosides, magnesium)
- •Patients with a history of allergy to rocuronium or sugammadex
研究组 & 干预措施
deep neuromuscular blockade
Rocuronium will be administered to achieve PTC 1-2 throughout surgery.
干预措施: Moderate neuromuscular blockade (Drug)
moderate neuromuscular blockade
Rocuronium will be administered to achieve TOFC 2 throughout surgery
干预措施: Deep neuromuscular blockade (Drug)
结局指标
主要结局
Deep block versus Moderate block: Impact on surgical satisfaction
时间窗: Every 15 minutes from first laparoscopic view till the removal of laparoscopes at the end of surgery or up to 8 hours from 1st score.
The surgeon will be required to score the quality of operating conditions every 15 minutes from 1st visualisation of peritoneal cavity until the removal of laparoscopes at the end of surgery.
次要结局
- Deep block versus Moderate block: Patient satisfaction score(Post Anesthetic Recovery Score done at half hour from time of arrival at PACU and patient deemed fit for discharge up to 2 hours from time of arrival at PACU)
- Deep block versus Moderate block: Pain score(Post Anesthetic Recovery Score done at half hour from time of arrival at PACU and patient deemed fit for discharge up to 2 hours from time of arrival at PACU)
- Deep block versus Moderate block: PONV Score(Post Anesthetic Recovery Score done at half hour from time of arrival at PACU and patient deemed fit for discharge up to 2 hours from time of arrival at PACU)
研究者
Loo Su Yin
Dr
Kuala Lumpur General Hospital