A RANDOMIZED CONTROL TRIAL COMPARING SPINAL ANAESTHESIA WITH GENERAL ANAESTHESIA ON DISCHARGE CRITERIA FOR DAY CARE URETEROSCOPIC SURGERIES
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Aldrete score 10
研究概览
简要总结
AIM: The aim of the study is to compare the effect of spinal anesthesia with general anesthesia on discharge criteria for day care ureteroscopic procedures.
· Primary objective: Attainment of discharge criteria · Secondary objective: to evaluate hemodynamics and occurrence of complications (Pain , Post operative nausea and vomiting).
Methodology: As per randomization cases are done under SA or GA((LMA Spontaneous) under standardized monitoring protocol
Shifted to Phase 1 recovery area where Aldrete score is checked. Patients are shifted to phase 2 recovery area when Aldrete score is 10
In Phase 2 recovery, monitoring continued for HR, NIBP, and Saturation. Patients will be made to sit in the bed with support in the 2nd hour (120 min).
During this time patients will be assessed for nausea. If no nausea complained, they will be encouraged to drink water.
At 2.5 hours (150 min) after surgery patients will be encouraged to sit at the edge of the cot with legs dangling down.
At 3 hours (180 min) they will be encouraged to stand with support (Staffs holding on either side). In spinal group standing was encouraged only after confirming return of Bromage to 1 (No detectable weakness in lower limbs).
If the patient had no complaint of giddiness they will be encouraged to walk from 4th hour (240 min).
PADSS score (Post anaesthesia discharge scoring system) which includes vital signs, gait, mental status, pain nausea and vomiting will be recorded in all patients from 4th hour (240 min) till score of 9 was achieved.
Patients will be discharged from phase 2 recovery at the end of 360 minutes i.e., 6th hour after reconfirming whether they have achieved PADSS score of 9. (In our patients PADSS of 10 will not be achieved as they will be catheterized).
Before discharge from phase 2 cognitive ability of patients using digit symbol substitution test method will be done.
Patient will be assessed for pain using VAS score and anytime VAS is above 4, rescue analgesic Inj. Tramadol 100mg IV will be given.
During recovery stay presence of complications like nausea, vomiting and shivering will be also recorded.
The surgeon was asked to grade their comfort during surgery which is recorded as satisfactory score. (4-excellent, 3- Good, 2- fair, 1-poor).
Results will be submitted to statistical analysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA 1 AND 2 patients
- •Patients posted for ureterolithotrypsy.
排除标准
- •Urinary tract infection.
- •Patients with contra indications for spinal anesthesia.
- •Patients with coronary artery disease
- •Patients with deranged renal parameters
- •Patients with deranged coagulation
- •6.Patient with history of bronchial asthma or chronic obstructive pulmonary disease.
- •Patients with allergy to any study medications.
- •ASA (American Society of Anaesthesiology) category III and IV.
- •Patient refusal for one or other technique of anaesthesia.
- •10.Surgeon requests for specific anaesthesia technique.
- •11.Pregnancy.
- •Patient refusal.
结局指标
主要结局
Aldrete score 10
时间窗: Sameday
次要结局
- Haemodynamics(same day)