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Analgesic Effect of Ketamine in Patients Undergoing Hysteroscopic Endometrial Thermal Ablation Surgery

This study is currently recruiting participants.
Verified February 2013 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Shireen Ahmad, Northwestern University
ClinicalTrials.gov Identifier:
NCT01106846
First received: April 16, 2010
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  Purpose

Hypothesis: The intraoperative administration of ketamine will result in a 30% reduction in opiate requirement following endometrial ablation surgery and the intraoperative administration of ketamine will result in a decreased time to meet discharge criteria in the PACU following endometrial ablation surgery.

The research question is "Does intraoperative administration of ketamine result in decreased postoperative opiate requirement and time to discharge from the postanesthesia recovery unit (PACU) following hysteroscopic endometrial ablation".


Condition Intervention
Pain
 Drug: Saline
Drug: Ketamine continuous infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Analgesic Effect of Ketamine in Patients Undergoing Hysteroscopic Endometrial Thermal Ablation Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Total dose of postoperative opioid [ Time Frame: 24 hours post operatively ] [ Designated as safety issue: No ]
    Total dose of opioids will be determined for up to 24 hours post operatively


Secondary Outcome Measures:
  • Total dose of intraoperative opioid [ Time Frame: intra operative period ] [ Designated as safety issue: No ]
    Total dose of intraoperative opioids used

  • Opiate related side effects: Nausea, vomiting, retching, sedation [ Time Frame: 24 hours post operatively ] [ Designated as safety issue: Yes ]
    Number of opiate related side effects: Nausea, vomiting, retching, sedation


Estimated Enrollment: 58
Study Start Date: February 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group A: Saline group
Group A: Saline group , infusion of saline
 Drug: Saline
Saline continuous infusion
Active Comparator: Group B: 1% Ketamine group
Infusion of ketamine
 Drug: Ketamine continuous infusion
Ketamine continuous infusion

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gender: Female
  • Age: 18-65 years
  • Non-pregnant, non-lactating
  • Surgery: Outpatient hysteroscopic Novasure® endometrial ablation
  • Language: English speaking
  • Consent: Obtained

Exclusion Criteria:

  • Patient refusal
  • Under 18 or over age 65
  • Non-English Speaking
  • Pregnancy, Breast feeding
  • Hysteroscopic procedures using Thermachoice® ablation device
  • Chronic use or addiction to opiates, sedatives, non-opiate analgesics
  • History of heavy alcohol usage (>4 drinks/day)
  • Significant cardiovascular or pulmonary disease
  • Psychiatric or emotional disorder
  • Allergy to anesthetic agents utilized in the protocol
  • Glaucoma
  • Thyrotoxicosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106846

Contacts
Contact: Shireen Ahmad, MD 312-472-0550 sah704@northwestern.edu

Locations
United States, Illinois
Prentice Women's Hosptial Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Robert McCarthy, PharmD     312-926-9015     r-mccarthy@northwestern.edu    
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Shireen Ahmad, MD     312-472-0050     sah704@northwestern.edu    
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Shireen Ahmad, MD Northwestern University
  More Information

Publications:

Responsible Party: Shireen Ahmad, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01106846     History of Changes
Other Study ID Numbers: STU00026695
Study First Received: April 16, 2010
Last Updated: February 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Ketamine
Anesthesia
Pain
Outpatient surgery

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Analgesics
Ketamine
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013