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

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ClinicalTrials.gov Identifier: NCT01106846
Recruitment Status : Terminated (Resources not available to complete.)
First Posted : April 20, 2010
Results First Posted : July 20, 2015
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):
Shireen Ahmad, Northwestern University

Tracking Information
First Submitted Date  ICMJE April 16, 2010
First Posted Date  ICMJE April 20, 2010
Results First Submitted Date  ICMJE June 18, 2015
Results First Posted Date  ICMJE July 20, 2015
Last Update Posted Date August 7, 2015
Study Start Date  ICMJE March 2010
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2015)
Quality of Recovery Score Post Operative at 24 Hours [ Time Frame: 24 hours post operative ]
Quality of recovery 40 score at 24 hours after the surgical procedure. 40 being a poor recovery and 200 being a good recovery.
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2010)
Total dose of postoperative opioid [ Time Frame: 24 hours post operatively ]
Total dose of opioids will be determined for up to 24 hours post operatively
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2010)
  • Total dose of intraoperative opioid [ Time Frame: intra operative period ]
    Total dose of intraoperative opioids used
  • Opiate related side effects: Nausea, vomiting, retching, sedation [ Time Frame: 24 hours post operatively ]
    Number of opiate related side effects: Nausea, vomiting, retching, sedation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analgesic Effect of Ketamine in Patients Undergoing Hysteroscopic Endometrial Thermal Ablation Surgery
Official Title  ICMJE Analgesic Effect of Ketamine in Patients Undergoing Hysteroscopic Endometrial Thermal Ablation Surgery
Brief Summary

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".

Detailed Description

Preoperatively:

Subjects will be recruited up to 21days prior to the day of surgery. After informed consent is obtained, subjects will be randomly assigned to one of two groups:

Group A: Saline group Group B: 1% Ketamine group

A verbal rating scale (VRS) will be used to assess pain preoperatively. The patient will be asked to identify the severity of pain by indicating on a scale of 0-10 where 0 is "no pain" and 10 is "the worst pain imaginable".

Baseline Quality of Recovery will be obtained. (Appendix F)

Subjects will be randomized prior to surgery to either Group A or Group B. The randomization table is computer generated. There is a 50% allocation to each group.

Intraoperatively:

Standard anesthetic monitoring will be used including monitoring of processed EEG including either the bi-spectral index (BIS) or similar standard of care ASA monitor. A standardized intraoperative anesthetic plan will be utilized by the anesthesia personnel. (Appendix A). Study drug will be prepared and labeled in 10mL syringes by research personnel who will not be involved in the study assessments. Study drug will be administered on initial insertion of Novasure® device (Appendix B).

Postoperatively:

Pain scores in the PACU will be assessed using the VRS upon admission and every 30 minutes thereafter until discharge criteria are met.

Additionally, nausea, vomiting and retching episodes will be recorded using a VRS.

Postoperative analgesic and antiemetic therapy will be standardized and total amounts of these agents will be recorded Assessment of psychomimetic effects including sedation and agitation will be assess postoperatively prior to discharge using the Richmond Agitation/Sedation Scale (Appendix D).

Acute recovery will be assessed using the Modified Post Anesthesia Discharge Scoring System (MPADSS) (Appendix E). A score of 8 or greater will indicate discharge readiness. Time to fulfill discharge criteria will be recorded.

Any other adverse events and medications required will be recorded. These data will be recorded by research personnel who will be blinded to the study group assignments.

Subjects will be contacted by telephone 24 hours after surgery to assess post-discharge quality of recovery (Appendix F).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Group A: Saline Group
    Saline continuous infusion
    Other Name: Saline
  • Drug: Group B: 1% Ketamine group
    Administration of 1% ketamine intravenously.
    Other Name: Ketamine
Study Arms  ICMJE
  • Placebo Comparator: Group A: Saline group
    Group A: Saline group , infusion of saline intravenously
    Intervention: Drug: Group A: Saline Group
  • Active Comparator: Group B: 1% Ketamine group
    Group B: Infusion of ketamine 1% intravenously
    Intervention: Drug: Group B: 1% Ketamine group
Publications *

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: July 16, 2015)
22
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2010)
58
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01106846
Other Study ID Numbers  ICMJE STU00026695
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shireen Ahmad, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shireen Ahmad, MD Northwestern University
PRS Account Northwestern University
Verification Date July 2015

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