Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Intraoperative IV Ketamine on Postoperative Morphine Consumption During Intestinal Surgery

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: NCT03344393
Recruitment Status : Unknown
Verified November 2017 by Mohamed galal aly, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed galal aly, Assiut University

Tracking Information
First Submitted Date  ICMJE November 9, 2017
First Posted Date  ICMJE November 17, 2017
Last Update Posted Date November 17, 2017
Estimated Study Start Date  ICMJE December 1, 2017
Estimated Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
morphine consumption [ Time Frame: 2 days postoperative ]
IV PCA
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
  • cortisol level [ Time Frame: 2 days postoperative ]
    salivary
  • alpha amylase level [ Time Frame: 2 days postoperative ]
    salivary
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 Effect of Intraoperative IV Ketamine on Postoperative Morphine Consumption During Intestinal Surgery
Official Title  ICMJE Effect of Intraoperative IV Ketamine on Postoperative Morphine Consumption During Intestinal Surgery and Its Effect on Salivary Cortisol and Alpha Amylase Levels
Brief Summary .The aim of this study is to identify the analgesic effect of intraoperative ketamine intravenous infusion on patients undergoing intestinal surgery and its effect on salivary cortisol and alpha amylase levels as indicator of its effect.
Detailed Description

I- Group K (ketamine): 30 patients will receive intraoperative intravenous ketamine infusion.

II- Group C (control): 30 patients will receive intraoperative intravenous normal saline infusion.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE Postoperative Analgesia
Intervention  ICMJE
  • Drug: Ketamine Hydrochloride
    intravenous ketamine infusion intraoperatively
    Other Name: ketalar
  • Drug: Normal saline
    intravenous normal saline infusion intraoperatively
    Other Name: Sodium chloride solution
Study Arms  ICMJE
  • Active Comparator: ketamine hydrochloride
    intravenous ketamine infusion in the intraoperative period
    Intervention: Drug: Ketamine Hydrochloride
  • Active Comparator: normal saline
    intravenous normal saline infusion in the intraoperative period
    Intervention: Drug: Normal saline
Publications * Arıkan M, Aslan B, Arıkan O, Horasanlı E, But A. Comparison of the effects of magnesium and ketamine on postoperative pain and morphine consumption. A double-blind randomized controlled clinical study. Acta Cir Bras. 2016 Jan;31(1):67-73. doi: 10.1590/S0102-865020160010000010.

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 13, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2019
Estimated Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • - Patient's status ASA status-I and II.
  • Patients age above 18 years old.
  • Patients scheduled for intestinal surgery.

Exclusion Criteria:

  • Patient refusal.
  • Patients with known allergy to ketamine or morphine.
  • Patients with significant hepatic dysfunction.
  • Patients with severe renal disease.
  • Significant Heart disease.
  • Patients with chronic pain.
  • Regular use analgesics, antidepressants or opioids in last 2 months.
  • Any known convulsive disorder.
  • Morbid obesity (BMI>35).
  • Patients with autoimmune disease
  • Patients on corticosteroid therapy
  • Pregnancy.
  • Breast feeding.
  • Woman under hormonal treatment.
  • Oral disease.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: above 18
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03344393
Other Study ID Numbers  ICMJE 17200147
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mohamed galal aly, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date November 2017

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