Back to resultsEffects of Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Cytokines
Primary Purpose
Endometrial Adenocarcinoma
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ketamine
dexmedetomidine
bupivacaine
Sponsored by
About this trial
This is an interventional prevention trial for Endometrial Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- ASA I-II patients
- age range (18-60) years,
- weight (50- 90) kg
Exclusion Criteria:
- allergy to study drugs
- significant cardiac disease
- respiratory disease
- renal disease
- hepatic disease
Sites / Locations
- South Egypt Cancer instIitute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
ketamine
dexmedetomidine
bupivacaine
Arm Description
Outcomes
Primary Outcome Measures
severity of pain at rest and on coughing
severity of pain at rest and on coughing will be assessed using a 10-cm Visual Analog Scale (0 = no pain and 10 = worst imaginable pain)
Secondary Outcome Measures
sedation
sedation by using sedation score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03164590
Brief Title
Effects of Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Cytokines
Official Title
Effects of Local Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Inflammatory Cytokines Response After Total Abdominal Hysterectomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to compare the effects of local wound infiltration with ketamine versus dexmedetomidine when added to bupivacaine on inflammatory cytokine response after total abdominal hysterectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Adenocarcinoma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ketamine
Arm Type
Active Comparator
Arm Title
dexmedetomidine
Arm Type
Active Comparator
Arm Title
bupivacaine
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
patients receive local anesthetic wound infiltration with 1 mg /kg ketamine
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine
Intervention Description
patients receive local anesthetic wound infiltration with 1µg/kg dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
bupivacaine
Intervention Description
patients receive local anesthetic wound infiltration with bupivacaine 0.5 % diluted in 20 ml saline
Primary Outcome Measure Information:
Title
severity of pain at rest and on coughing
Description
severity of pain at rest and on coughing will be assessed using a 10-cm Visual Analog Scale (0 = no pain and 10 = worst imaginable pain)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
sedation
Description
sedation by using sedation score
Time Frame
24 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA I-II patients
age range (18-60) years,
weight (50- 90) kg
Exclusion Criteria:
allergy to study drugs
significant cardiac disease
respiratory disease
renal disease
hepatic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fatma el sherif, MD
Organizational Affiliation
South Egypt Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Egypt Cancer instIitute
City
Assuit
ZIP/Postal Code
171516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Cytokines
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