Analgesic Effect of Ketamine in Patients Undergoing Hysteroscopic Endometrial Thermal Ablation Surgery
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".
|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|
- Quality of Recovery Score Post Operative at 24 Hours [ Time Frame: 24 hours post operative ] [ Designated as safety issue: No ]Quality of recovery 40 score at 24 hours after the surgical procedure.
|Study Start Date:||March 2010|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Group A: Saline group
Group A: Saline group , infusion of saline intravenously
Drug: Group A: Saline Group
Saline continuous infusion
Other Name: Saline
Active Comparator: Group B: 1% Ketamine group
Group B: Infusion of ketamine 1% intravenously
Drug: Group B: 1% Ketamine group
Administration of 1% ketamine intravenously.
Other Name: Ketamine
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.
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).
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106846
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Prentice Women's Hosptial|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Shireen Ahmad, MD||Northwestern University|