Evaluation of effects of pre-operative anxiety on peri-operative hemodynamic parameters in adult patients undergoing elective laparoscopic cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- To correlate the effect of pre-operative trait anxiety score calculated by State-Trait Anxiety Inventory (STAI) with % change in Mean Blood Pressure during the induction of anaesthesia in adult patients undergoing elective laparoscopic cholecystectomy.
研究概览
简要总结
This study is a prospective observational cohort study, evaluating the effects of pre-operative anxiety on peri-operative hemodynamic parameters in adult patients undergoing elective laparoscopic cholecystectomy under general anaesthesia in a single centre in India. The primary outcome measure will be correlation of the effect of pre-operative trait anxiety score calculated by State - Trait Anxiety Inventory ( STAI ) with % change in mean blood pressure during the inducion of anaesthesia. The secondary outcomes will be correlation of the effect of pre-operative anxiety score calculated by STAI with -
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Induction hemodynamics ( % change in mean blood pressure, heart rate, systolic blood pressure, diastolic blood pressure)
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Intra-operative hemodynamics
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Need for additional propofol dose for induction and intra-operative anesthetic requirement i.e. intra-operative dose of fentanyl
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Post-operative pain using Visual Analogue Scale ( VAS ) score.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •The patient subjects are adult patients (18-65 years) of either gender who are American Society of Anesthesiologists (ASA) Grade I and are posted for elective laparoscopic cholecystectomy under general anesthesia.
排除标准
- •Patients with history of psychiatric illness, treatment with anti depressants and anxiolytics, frequently taking sleeping pills or sedatives.
- •Patients with Central Nervous System diseases.
- •Pregnant patients.
- •Patients with anticipated difficult airway.
结局指标
主要结局
To correlate the effect of pre-operative trait anxiety score calculated by State-Trait Anxiety Inventory (STAI) with % change in Mean Blood Pressure during the induction of anaesthesia in adult patients undergoing elective laparoscopic cholecystectomy.
时间窗: At the end of surgery
次要结局
- To correlate the effect of pre-operative anxiety score calculated by State-Trait Anxiety Inventory (STAI) with induction hemodynamics (% change in Mean Blood Pressure, Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure) in adult patients undergoing elective laparoscopic cholecystectomy.(At the end of surgery)
- To correlate the effect of pre-operative anxiety score calculated by State-Trait Anxiety Inventory (STAI) with intra-operative hemodynamics in adult patients undergoing elective laparoscopic cholecystectomy.(At the end of surgery)
- To correlate the effect of pre-operative anxiety score calculated by State-Trait Anxiety Inventory (STAI) with need for additional propofol dose for induction and intra-operative anesthetic requirement i.e. intra-operative dose of fentanyl in adult patients undergoing elective laparoscopic cholecystectomy.(At the end of surgery)
- To correlate the effect of pre-operative anxiety score calculated by State-Trait Anxiety Inventory (STAI) with post-operative pain using Visual analogue scale (VAS) score.(1. At the end of surgery)