Comparison of Desflurane Balanced Anesthesia Versus TIVA-TCI (Total IntraVenous Anesthesia-Target Controlled Infusion) in Patients Undergoing Ophthalmic Ambulatory Surgery: A Single Center, Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 209
- 试验地点
- 1
- 主要终点
- Awake time
研究概览
简要总结
This is a single-center, randomized, prospective research which aims to investigate the advantages and disadvantages between desflurane balanced anesthesia and TIVA-TCI with propofol in ophthalmic ambulatory surgery, so that to evaluate a better anesthesia method in ophthalmic surgery through a large sample clinical study.
详细描述
Desflurane balanced anesthesia and TIVA-TCI(Total IntraVenous Anesthesia-Target Controlled Infusion) are commonly used in ophthalmic ambulatory surgery, however, there is no clear evidence to discriminate the advantages and disadvantages between them. This study is designed to evaluate a better anesthetic method in ophthalmic surgery through a clinical study. This is a single center, randomized, prospective study. 200 patients with American Society of Anesthesiologists'(ASA) physical status 1 to 2, aged 18 to 60, scheduled for elective strabismus ambulatory and in whom a LMA is indicated for anesthesia are recruited. Enrolled patients are randomly assigned into 2 groups: group TIVA (TIVA-TCI with propofol) and group Des (Desflurane).In group TIVA, anesthesia is maintained with propofol and remifentanil. Propofol is continuously administered via a target-controlled infusion (TCI) pump intraoperatively. In group Des, anesthesia is maintained with desflurane.All patients received anaesthesia depth monitoring with bispectral index (BIS). The dose of anesthetic is adjusted to maintained the BIS value within 40 to 60. At the end of the surgery, inhalant anesthetic or infused propofol and remifentanil are discontinued. LMA is removed when patient regains consciousness with spontaneous respiration. Patients are then transferred to the post anesthetic care unit (PACU) for postoperative follow-up. The primary outcome is awake time, the secondary outcomes include discharge time, the stay time in PACU, time of off-bed, Riker sedation agitation score (SAS), time of PADSS>9, NRS score when leaving PACU, incidence of various complications (postoperative nausea and vomiting (PONV), emergence agitation, etc), as well as anesthesia cost. All patients are followed up by calling in one day after the surgery.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-60 years patients undergoing selective ophthalmic ambulatory surgery；
- •ASA I and II
- •duration of anesthesia at least 30min
- •without apparent organ comorbidities
- •sign the informed consent form
排除标准
- •equal or greater than ASA III
- •has a history of dementia，psychiatric disorders or central nervous system diseases
- •taking sedatives, antidepressant or glucocorticoid
- •without family members
- •has cardiac, respiratory，liver，kidney comorbidities
- •uncontrolled hypertension（>180/100mmHg）
- •laryngeal mask fail to insert, and change to tracheal intubation
研究组 & 干预措施
Group TIVA
method of anesthesia is total intravenous anesthesia(TIVA) and maintenance with propofol Cp 2-4 μg/ml and remifentanil 2-4 ng/ml in target controlled infusion(TCI) during the procedure
干预措施: total intravenous anesthesia (Procedure)
Group TIVA
method of anesthesia is total intravenous anesthesia(TIVA) and maintenance with propofol Cp 2-4 μg/ml and remifentanil 2-4 ng/ml in target controlled infusion(TCI) during the procedure
干预措施: Propofol (Drug)
Group TIVA
method of anesthesia is total intravenous anesthesia(TIVA) and maintenance with propofol Cp 2-4 μg/ml and remifentanil 2-4 ng/ml in target controlled infusion(TCI) during the procedure
干预措施: Remifentanil (Drug)
Group Des
method of anesthesia is inhalation anesthesia and maintenance with desflurane ranged from 0.5~1.5 MAC during the procedure
干预措施: desflurane (Drug)
Group Des
method of anesthesia is inhalation anesthesia and maintenance with desflurane ranged from 0.5~1.5 MAC during the procedure
干预措施: inhalation anesthesia (Procedure)
结局指标
主要结局
Awake time
时间窗: From the ending time of anesthesia until the recovery time of patient's consciousness, assessed up to half an hour postoperatively.
"Anesthesia ends" means stop infusing or inhaling any anaesthetic.
次要结局
- Postoperative VAS pain score(Start scaling in half an hour postoperatively when patient's consciousness returns.)
- Discharge time(From the ending time of anesthesia until the time of extubation, assessed up to half an hour postoperatively.)
- Stay time in the postoperative care unit(Measuring the stay time in postoperative care unit, assessed up to one hour postoperatively.)
- Quality of recovery in 1 day postoperatively(Start scaling when 1 day(24 hour) postoperatively.)
- Incidences in postoperative nausea and vomiting(PONV)(Start scaling in 1 day(24 hour) postoperatively.)
- Anesthesia cost(During the procedure of anesthesia.)
- Incidences in postoperative agitation(Start scaling in 1 day(24 hour) postoperatively.)
研究者
Xiaoliang Gan
associate chief physician
Sun Yat-sen University