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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03535025
Other study ID # IRC/1090/017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2, 2018
Est. completion date November 30, 2018

Study information

Verified date January 2019
Source B.P. Koirala Institute of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigator's study is designed to evaluate the recovery of patients receiving anaesthesia for surgeries; in different domains like the physiological, nociceptive, cognitive and emotional to the participants' preoperative state.


Recruitment information / eligibility

Status Completed
Enrollment 195
Est. completion date November 30, 2018
Est. primary completion date November 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients aged 18 years or over who are undergoing surgery with anesthesia

Exclusion Criteria:

- Inability to complete the baseline questionnaire for any reason as assessed by the examiner

- Patient with any current psychiatric disturbance

- Patient undergoing a neuropsychological procedure that may impair their ability to participate in the assessment

- Patients undergoing emergency surgery

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Nepal BPKIHS Dharan Bazar Sunsari

Sponsors (1)

Lead Sponsor Collaborator
B.P. Koirala Institute of Health Sciences

Country where clinical trial is conducted

Nepal, 

Outcome

Type Measure Description Time frame Safety issue
Primary quality of recovery from anaesthesia include the quality of recovery in each domain over the postoperative follow-up period as compared to the same in preoperative period (baseline value) using the postoperative quality of recovery scale. The different domains include physiological (with subdomains: systolic blood pressure, heart rate, temperature, respiratory rate, oxygen requirement, airway, agitation, consciousness and ability to lift head, each scoring from 1 to 3), nociceptive ( scoring 1to 5, higher score means more pain), emotional (1 to 5), activity of daily living( 1 to 3), cognitive ( with subdomains orientation(1 to 3), number forward and backward(1 to 6), word task and executive memory) and impact on ability to work(1 to 3) 24 hours post operatively
Secondary factors delaying recovery factors associated with delay in recovery from anaesthesia for surgery 24 hrs post operatively