Evaluation & comparison of the effect of same versus different anaesthesiologist on preoperative visits on preoperative anxiety & quality of recovery- a randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pre-operative anxiety of the patients will be assessed using APAIS score
研究概览
简要总结
Preoperative anxiety is common among the patients going for elective surgeries. Various pharmacological and non- pharmacological methods are employed to prevent it. Non pharmacological approaches are gaining popularity as pharmacological interventions have the potential to have negative side effects, such as respiratory issues, drowsiness, interacting with anaesthetic medications and extended recovery.
The objectives are to assess and compare the pre-operative anxiety using APAIS score a day prior to surgery in ward and morning of surgery , Quality of recovery using QoR-15 questionnaire at the end of day one of surgery, NRS- P (Numeric Rating Scale for Pain) at 1st ,3rd ,6th ,12th ,24th hours after completion of surgery, Time to reach Modified Aldrete Score ≥ 9, Patient satisfaction score using Likert scale
This Randomized controlled trial study includes 90 female patients between 18-60 years of age undergoing laparoscopic cholecystectomy under general Anaesthesia. Patients will be randomized into one of the two groups, a day before surgery
Group-D (Control group)- Different anaesthesiologists on both preoperative visits
Group- S (Intervention Group)- Same anaesthesiologists on both preoperative visits
During both the visits, the anaesthesiologist will assess POA utilizing Amsterdam Preoperative Anxiety and Information Scale (APAIS).
Patients in both the groups will receive GA (General Anaesthesia) as per standard protocol. In postoperative period pain will be assessed via a Numeric rating scale-Pain (NRS-P) score at the end of 1st, 3rd,6th, 12th and 24th hour after completion of surgery, Time to reach Modified Aldrete Score ≥9, Patient satisfaction using Likert scale and Quality of Recovery at the end of day one of surgery using QoR-15 questionnaire.
The primary outcome is comparison between APAIS Scores , QoR-15 score, NRS-Pain scores at different time points, Time to reach MAS≥ 9, Patients satisfaction score
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 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Consenting female patients between 18-60 years of age undergoing laparoscopic cholecystectomy under General Anaesthesia will be assessed for eligibility and included in the study.
排除标准
- •History of past surgeries, was exposed to theatre environment prior, mental illness and inability to comprehend questionnaires.
结局指标
主要结局
Pre-operative anxiety of the patients will be assessed using APAIS score
时间窗: APAIS score will be assessed day prior to surgery in ward during pre anaesthetic checkup i.e. baseline and on the morning of surgery before starting of surgery
次要结局
- 1.Postoperative pain will be assessed via a Numeric Rating Scale for Pain (NRS-P).(2.Time to reach Modified Aldrete score ≥ 9.)