- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03535025
Postoperative Quality of Recovery in Patients Receiving Anaesthesia
January 29, 2019 updated by: Sachin Koirala, B.P. Koirala Institute of Health Sciences
Postoperative Quality of Recovery in Patients Receiving Anaesthesia: A Prospective Observational Study
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
195
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sunsari
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Dharān Bāzār, Sunsari, Nepal, 025
- BPKIHS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
all patients above the age of 18yrs under going elective surgery under anaesthesia
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quality of recovery from anaesthesia
Time Frame: 24 hours post operatively
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
factors delaying recovery
Time Frame: 24 hrs post operatively
|
factors associated with delay in recovery from anaesthesia for surgery
|
24 hrs post operatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2018
Primary Completion (Actual)
November 30, 2018
Study Completion (Actual)
November 30, 2018
Study Registration Dates
First Submitted
April 15, 2018
First Submitted That Met QC Criteria
May 12, 2018
First Posted (Actual)
May 24, 2018
Study Record Updates
Last Update Posted (Actual)
January 30, 2019
Last Update Submitted That Met QC Criteria
January 29, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- IRC/1090/017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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