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

• ClinicalTrials.gov Identifier: NCT03164590
• Recruitment Status: Completed
• First Posted: May 23, 2017
• Last Update Posted: January 22, 2020
• Sponsor: Assiut University
• Information provided by (Responsible Party): Fatma Adel El sherif,MD, Assiut University

Tracking Information

• First Submitted Date: May 22, 2017
• First Posted Date: May 23, 2017
• Last Update Posted Date: January 22, 2020
• Actual Study Start Date: June 1, 2017
• Actual Primary Completion Date: August 1, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (submitted: May 22, 2017)

sedation [ Time Frame: 24 hours ]

sedation by using sedation score

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Cytokines
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Endometrial Adenocarcinoma

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 28, 2018): 60
• Original Estimated Enrollment (submitted: May 22, 2017): 90
• Actual Study Completion Date: September 1, 2018
• Actual Primary Completion Date: August 1, 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT03164590
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Fatma Adel El sherif,MD, Assiut University
• Study Sponsor: Assiut University
• Collaborators: Not Provided

Investigators

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

• PRS Account: Assiut University
• Verification Date: January 2018