- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02362022
The Effects of Morphine on Desflurane Consumption and Recovery Time
December 2, 2015 updated by: CAGLA BALI,MD, Baskent University
Comparison of Two Different Doses of Intravenous Morphine on Desflurane Consumption and Recovery Time in Patients Undergoing Total Abdominal Hysterectomy
Combination of volatile and opioid agents are used to achieve unconsciousness, haemodynamic stability and analgesia for surgical prosedures.
This prospective, randomized, double-blind, controlled study evaluates the effects of two different doses of morphine sulphate (0.1 mg/kg and 0.2 mg/kg), on desflurane consumption, recovery characteristics, postoperative analgesic requirements and side effects during total abdominal hysterectomy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Phase 4
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
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-
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Adana, Turkey, 01250
- Baskent University School of Medicine Adana Teaching and Research Hospital
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-
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
40 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- undergoing total abdominal hysterectomy with general anaesthesia
Exclusion Criteria:
- renal dysfunction (cre>1.2), liver failure, cardiovascular, psychiatric, allergic and metabolic disorders
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Group Saline
Group Saline (Group S) received i.v saline 0.9 % in 10 ml volume (n=30)
|
Group Saline (Group S): Received i.v saline 0.9 % in 10 ml volume (n=30) Group Morphine 1 (Group M1): Received i.v morphine 0.1 mg kg-1 in 10 ml volume (n=30) Group Morphine 2 (Group M2): Received i.v morphine 0.2 mg kg-1 in 10 ml volume (n=30)
|
|
Active Comparator: Group Morphine 1
Group Morphine 1 (Group M1) received i.v morphine 0.1 mg kg-1, in 10 ml volume (n=30)
|
Group Saline (Group S): Received i.v saline 0.9 % in 10 ml volume (n=30) Group Morphine 1 (Group M1): Received i.v morphine 0.1 mg kg-1 in 10 ml volume (n=30) Group Morphine 2 (Group M2): Received i.v morphine 0.2 mg kg-1 in 10 ml volume (n=30)
|
|
Active Comparator: Group Morphine 2
Group Morphine 2 (Group M2) received i.v morphine 0.2 mg kg-1, in 10 ml volume (n=30)
|
Group Saline (Group S): Received i.v saline 0.9 % in 10 ml volume (n=30) Group Morphine 1 (Group M1): Received i.v morphine 0.1 mg kg-1 in 10 ml volume (n=30) Group Morphine 2 (Group M2): Received i.v morphine 0.2 mg kg-1 in 10 ml volume (n=30)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
postoperative desflurane consumption
Time Frame: postoperative first hour
|
postoperative first hour
|
|
sedation scores for OASS scale
Time Frame: postoperative first hour
|
postoperative first hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: cagla bali, Baskent University
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
September 1, 2007
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
February 4, 2015
First Submitted That Met QC Criteria
February 7, 2015
First Posted (Estimate)
February 12, 2015
Study Record Updates
Last Update Posted (Estimate)
December 3, 2015
Last Update Submitted That Met QC Criteria
December 2, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14.09.2007/88-4
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.