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

NCT ID: NCT03164590

Last Updated: 2020-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Endometrial Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ketamine

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

patients receive local anesthetic wound infiltration with 1 mg /kg ketamine

dexmedetomidine

Group Type ACTIVE_COMPARATOR

dexmedetomidine

Intervention Type DRUG

patients receive local anesthetic wound infiltration with 1µg/kg dexmedetomidine

bupivacaine

Group Type PLACEBO_COMPARATOR

Ketamine

Intervention Type DRUG

patients receive local anesthetic wound infiltration with 1 mg /kg ketamine

dexmedetomidine

Intervention Type DRUG

patients receive local anesthetic wound infiltration with 1µg/kg dexmedetomidine

bupivacaine

Intervention Type DRUG

patients receive local anesthetic wound infiltration with bupivacaine 0.5 % diluted in 20 ml saline

Interventions

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Ketamine

patients receive local anesthetic wound infiltration with 1 mg /kg ketamine

Intervention Type DRUG

dexmedetomidine

patients receive local anesthetic wound infiltration with 1µg/kg dexmedetomidine

Intervention Type DRUG

bupivacaine

patients receive local anesthetic wound infiltration with bupivacaine 0.5 % diluted in 20 ml saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Adel El sherif,MD

lecturer of anesthesia ,ICU and pain releif

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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fatma el sherif, MD

Role: PRINCIPAL_INVESTIGATOR

South Egypt Cancer Institute

Locations

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South Egypt Cancer instIitute

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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388

Identifier Type: -

Identifier Source: org_study_id

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