Effect of Intraoperative IV Ketamine on Postoperative Morphine Consumption During Intestinal Surgery
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
.The aim of this study is to identify the analgesic effect of intraoperative ketamine intravenous infusion on patients undergoing intestinal surgery and its effect on salivary cortisol and alpha amylase levels as indicator of its effect.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2017
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
First Submitted
Initial submission to the registry
November 9, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedStudy Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedNovember 17, 2017
November 1, 2017
1.1 years
November 9, 2017
November 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
morphine consumption
IV PCA
2 days postoperative
Secondary Outcomes (2)
cortisol level
2 days postoperative
alpha amylase level
2 days postoperative
Study Arms (2)
ketamine hydrochloride
ACTIVE COMPARATORintravenous ketamine infusion in the intraoperative period
normal saline
ACTIVE COMPARATORintravenous normal saline infusion in the intraoperative period
Interventions
intravenous ketamine infusion intraoperatively
intravenous normal saline infusion intraoperatively
Eligibility Criteria
You may qualify if:
- \- Patient's status ASA status-I and II.
- Patients age above 18 years old.
- Patients scheduled for intestinal surgery.
You may not qualify if:
- Patient refusal.
- Patients with known allergy to ketamine or morphine.
- Patients with significant hepatic dysfunction.
- Patients with severe renal disease.
- Significant Heart disease.
- Patients with chronic pain.
- Regular use analgesics, antidepressants or opioids in last 2 months.
- Any known convulsive disorder.
- Morbid obesity (BMI\>35).
- Patients with autoimmune disease
- Patients on corticosteroid therapy
- Pregnancy.
- Breast feeding.
- Woman under hormonal treatment.
- Oral disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Arikan M, Aslan B, Arikan O, Horasanli E, But A. Comparison of the effects of magnesium and ketamine on postoperative pain and morphine consumption. A double-blind randomized controlled clinical study. Acta Cir Bras. 2016 Jan;31(1):67-73. doi: 10.1590/S0102-865020160010000010.
PMID: 26840358BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 9, 2017
First Posted
November 17, 2017
Study Start
December 1, 2017
Primary Completion
January 1, 2019
Study Completion
March 1, 2019
Last Updated
November 17, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share