Effects of Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Cytokines

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03164590
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Actual Duration (Months): 15
• Patients Per Site Per Month: 4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Adenocarcinoma	Drug: Ketamine; Drug: dexmedetomidine; Drug: bupivacaine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effects of Local Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Inflammatory Cytokines Response After Total Abdominal Hysterectomy
• Actual Study Start Date: Jun 1, 2017
• Actual Primary Completion Date: Aug 1, 2018
• Actual Study Completion Date: Sep 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ketamine	Drug: Ketamine; patients receive local anesthetic wound infiltration with 1 mg /kg ketamine
Active Comparator: dexmedetomidine	Drug: dexmedetomidine; patients receive local anesthetic wound infiltration with 1µg/kg dexmedetomidine
Placebo Comparator: bupivacaine	Drug: Ketamine; patients receive local anesthetic wound infiltration with 1 mg /kg ketamine; Drug: dexmedetomidine; patients receive local anesthetic wound infiltration with 1µg/kg dexmedetomidine; Drug: bupivacaine; patients receive local anesthetic wound infiltration with bupivacaine 0.5 % diluted in 20 ml saline

Outcome Measures

Primary Outcome Measures

1. severity of pain at rest and on coughing [24 hours]

   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

1. sedation [24 hours]

   sedation by using sedation score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Egypt Cancer instIitute	Assuit		Egypt	171516

Sponsors and Collaborators

• Assiut University

Investigators

• Principal Investigator: fatma el sherif, MD, South Egypt Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fatma Adel El sherif,MD, lecturer of anesthesia ,ICU and pain releif, Assiut University
• ClinicalTrials.gov Identifier: NCT03164590
• Other Study ID Numbers: 388
• First Posted: May 23, 2017
• Last Update Posted: Jan 22, 2020
• Last Verified: Jan 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Adenocarcinoma; Dexmedetomidine; Ketamine; Bupivacaine

Study Results

No Results Posted as of Jan 22, 2020