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Comparing Three Different Doses of Intrathecal Ketamine

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ClinicalTrials.gov Identifier: NCT05074823
Recruitment Status : Not yet recruiting
First Posted : October 12, 2021
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
Mostafa Samy Abbas, Assiut University

Tracking Information
First Submitted Date  ICMJE September 22, 2021
First Posted Date  ICMJE October 12, 2021
Last Update Posted Date October 20, 2021
Estimated Study Start Date  ICMJE January 10, 2022
Estimated Primary Completion Date August 10, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2021)
Time to first analgesic request [ Time Frame: First 24 hours ]
From the time of intrathecal administration of the drug to the time of patient needs the first rescue analgesic drug
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Three Different Doses of Intrathecal Ketamine
Official Title  ICMJE Analgesic Effects of Three Different Doses of Intrathecal Ketamine as an Adjuvant to Intrathecal Bupivacaine in Patients Undergoing Knee Arthroscopy. A Randomized Prospective Double-blinded Study
Brief Summary The aim of this study is to compare the postoperative analgesic effect of three different doses of intrathecal ketamine as an adjuvant to bupivacaine in patients undergoing knee arthroscopy.
Detailed Description

A meta-analysis of adult human randomized controlled studies that compared single dose perioperative intrathecal ketamine plus intrathecal bupivacaine to bupivacaine alone in spinal anesthesia suggests that there is a benefit to using intrathecal ketamine as an adjunct to bupivacaine in multimodal analgesia. However, there are still knowledge and experience gaps regarding neuraxial ketamine dosing in this regard.

Aim of the study:

The aim of this study is to compare the postoperative analgesic effect of three different doses of intrathecal ketamine as an adjuvant to bupivacaine in patients undergoing knee arthroscopy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Ketamine Causing Adverse Effects in Therapeutic Use
Intervention  ICMJE
  • Drug: Ketamine 0.1 mg
    Patients will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.1 mg/kg
  • Drug: Ketamine 0.2 mg
    will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.2 mg/kg
  • Drug: Ketamine 0.3 mg
    will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.3 mg/kg
Study Arms  ICMJE
  • Active Comparator: Ketamine 0.1
    Group I: will include 35 patients, will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.1 mg/kg
    Intervention: Drug: Ketamine 0.1 mg
  • Active Comparator: Ketamine 0.2
    Group II will include 35 patients, will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.2 mg/kg
    Intervention: Drug: Ketamine 0.2 mg
  • Active Comparator: Ketamine 0.3
    Group III will include 35 patients, will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.3 mg/kg
    Intervention: Drug: Ketamine 0.3 mg
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 29, 2021)
105
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 11, 2022
Estimated Primary Completion Date August 10, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age: 18-70 years.
  • BMI: 20-30 kg.m2
  • Sex: both males and females.
  • ASA physical status: I-III.
  • Operation: knee arthroscopy.

Exclusion Criteria:

  • Patient's refusal to participate in the study.
  • Aged less than 18 years,
  • known allergy to L.A.,
  • Coagulopathy or thrombocytopenia,
  • height less than 150 cm, morbidly obese infection at the site of injection.
  • Chronic pain syndromes,
  • pregnant woman
  • Patients on regular use of analgesic or who received analgesic 24 h before surgery.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mostafa S Abbas, MD 01003060187 mostafasamy@aun.edu.eg
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05074823
Other Study ID Numbers  ICMJE Ketamine 3 doses
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: Undecided
Responsible Party Mostafa Samy Abbas, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date October 2021

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