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

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ClinicalTrials.gov Identifier: NCT03164590
Recruitment Status : Completed
First Posted : May 23, 2017
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Fatma Adel El sherif,MD, Assiut University

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

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Study Type : Interventional  (Clinical Trial)
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 : June 1, 2017
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. severity of pain at rest and on coughing [ Time Frame: 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 [ Time Frame: 24 hours ]
    sedation by using sedation score



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03164590


Locations
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Egypt
South Egypt Cancer instIitute
Assuit, Egypt, 171516
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: fatma el sherif, MD South Egypt Cancer Institute

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Responsible Party: Fatma Adel El sherif,MD, lecturer of anesthesia ,ICU and pain releif, Assiut University
ClinicalTrials.gov Identifier: NCT03164590     History of Changes
Other Study ID Numbers: 388
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Dexmedetomidine
Ketamine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
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
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents