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


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Verified May 2017 by Assiut University

Sponsor:

Information provided by (Responsible Party):

Fatma Adel El sherif, Assiut University

ClinicalTrials.gov Identifier:

NCT03164590

First received: May 22, 2017

Last updated: May 22, 2017

Last verified: May 2017

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.

Endometrial Adenocarcinoma Drug: Ketamine
Drug: dexmedetomidine
Drug: bupivacaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment: 90
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03164590

Assiut University

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

Responsible Party: Fatma Adel El sherif, lecturer of anesthesia ,ICU and pain releif, Assiut University
ClinicalTrials.gov Identifier: NCT03164590     History of Changes
Other Study ID Numbers: 388
Study First Received: May 22, 2017
Last Updated: May 22, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

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
Uterine Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Dexmedetomidine
Ketamine
Bupivacaine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on May 23, 2017