Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    "Endometrial Adenocarcinoma" | "Anesthetics, Dissociative"
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 22, 2017
First Posted Date  ICMJE May 23, 2017
Last Update Posted Date September 27, 2018
Actual Study Start Date  ICMJE June 1, 2017
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03164590 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2017)
sedation [ Time Frame: 24 hours ]
sedation by using sedation score
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Cytokines
Official Title  ICMJE Effects of Local Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Inflammatory Cytokines Response After Total Abdominal Hysterectomy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Endometrial Adenocarcinoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: ketamine
    Intervention: Drug: Ketamine
  • Active Comparator: dexmedetomidine
    Intervention: Drug: dexmedetomidine
  • Placebo Comparator: bupivacaine
    Interventions:
    • Drug: Ketamine
    • Drug: dexmedetomidine
    • Drug: bupivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2018)
60
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2017)
90
Actual Study Completion Date  ICMJE September 1, 2018
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03164590
Other Study ID Numbers  ICMJE 388
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Fatma Adel El sherif,MD, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: fatma el sherif, MD South Egypt Cancer Institute
PRS Account Assiut University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP