NCT03535025

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

11 months

First QC Date

April 15, 2018

Last Update Submit

January 29, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • factors delaying recovery

    24 hrs post operatively

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients above the age of 18yrs under going elective surgery under anaesthesia

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BPKIHS

Dharān, Sunsari, 025, Nepal

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Junior Resident

Study Record Dates

First Submitted

April 15, 2018

First Posted

May 24, 2018

Study Start

January 2, 2018

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

January 30, 2019

Record last verified: 2019-01

Locations