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

This study has been terminated.
(Resources not available to complete.)
Information provided by (Responsible Party):
Shireen Ahmad, Northwestern University Identifier:
First received: April 16, 2010
Last updated: February 2, 2015
Last verified: February 2015

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
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:

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

Enrollment: 27
Study Start Date: February 2010
Study Completion Date: March 2014
Primary Completion Date: March 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


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

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
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Please refer to this study by its identifier: NCT01106846

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Prentice Women's Hosptial
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Principal Investigator: Shireen Ahmad, MD Northwestern University
  More Information


Responsible Party: Shireen Ahmad, Principal Investigator, Northwestern University Identifier: NCT01106846     History of Changes
Other Study ID Numbers: STU00026695
Study First Received: April 16, 2010
Last Updated: February 2, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Outpatient surgery

Additional relevant MeSH terms:
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on July 05, 2015