Pre-operative anxiety and its effects on peri-operative hemodynamic parameters in adult patients undergoing elective surgery under general anaesthesia

Not yet recruiting

Conditions: Diseases of the digestive system,

Registration Number: CTRI/2021/02/031091

Lead Sponsor: Ira Sharma

Brief Summary: 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 -

1. Induction hemodynamics ( % change in mean blood pressure, heart rate, systolic blood pressure, diastolic blood pressure)

2. Intra-operative hemodynamics

3. Need for additional propofol dose for induction and intra-operative anesthetic requirement i.e. intra-operative dose of fentanyl

4. Post-operative pain using Visual Analogue Scale ( VAS ) score.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 35

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	At the end of surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): Safdarjung Hospital
🇮🇳
South, DELHI, India
Safdarjung Hospital
🇮🇳South, DELHI, India
Suniti Kale
Principal investigator
9810287852
findsuniti@gmail.com