NCT01106846

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".

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable pain

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 20, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

July 20, 2015

Completed
Last Updated

August 7, 2015

Status Verified

July 1, 2015

Enrollment Period

3 years

First QC Date

April 16, 2010

Results QC Date

June 18, 2015

Last Update Submit

July 20, 2015

Conditions

Pain

Keywords

KetamineAnesthesiaPainOutpatient surgery

Outcome Measures

Primary Outcomes (1)

  • Quality of Recovery Score Post Operative at 24 Hours

    Quality of recovery 40 score at 24 hours after the surgical procedure. 40 being a poor recovery and 200 being a good recovery.

    24 hours post operative

Study Arms (2)

Group A: Saline group

PLACEBO COMPARATOR

Group A: Saline group , infusion of saline intravenously

Drug: Group A: Saline Group

Group B: 1% Ketamine group

ACTIVE COMPARATOR

Group B: Infusion of ketamine 1% intravenously

Drug: Group B: 1% Ketamine group

Interventions

Group A: Saline GroupDRUG

Saline continuous infusion

Also known as: Saline
Group A: Saline group
Group B: 1% Ketamine groupDRUG

Administration of 1% ketamine intravenously.

Also known as: Ketamine
Group B: 1% Ketamine group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Prentice Women's Hosptial

Chicago, Illinois, 60611, United States

Location

Related Publications (9)

  • Schenker JG, Margalioth EJ. Intrauterine adhesions: an updated appraisal. Fertil Steril. 1982 May;37(5):593-610. doi: 10.1016/s0015-0282(16)46268-0. No abstract available.

    PMID: 6281085BACKGROUND

  • Jansen FW, Vredevoogd CB, van Ulzen K, Hermans J, Trimbos JB, Trimbos-Kemper TC. Complications of hysteroscopy: a prospective, multicenter study. Obstet Gynecol. 2000 Aug;96(2):266-70. doi: 10.1016/s0029-7844(00)00865-6.

    PMID: 10908775BACKGROUND

  • Wong AY, Wong K, Tang LC. Stepwise pain score analysis of the effect of local lignocaine on outpatient hysteroscopy: a randomized, double-blind, placebo-controlled trial. Fertil Steril. 2000 Jun;73(6):1234-7. doi: 10.1016/s0015-0282(00)00498-2.

    PMID: 10856489BACKGROUND

  • Lau WC, Ho RY, Tsang MK, Yuen PM. Patient's acceptance of outpatient hysteroscopy. Gynecol Obstet Invest. 1999;47(3):191-3. doi: 10.1159/000010092.

    PMID: 10087415BACKGROUND

  • De Iaco P, Marabini A, Stefanetti M, Del Vecchio C, Bovicelli L. Acceptability and pain of outpatient hysteroscopy. J Am Assoc Gynecol Laparosc. 2000 Feb;7(1):71-5. doi: 10.1016/s1074-3804(00)80012-2.

    PMID: 10648742BACKGROUND

  • MacPherson RD, Woods D, Penfold J. Ketamine and midazolam delivered by patient-controlled analgesia in relieving pain associated with burns dressings. Clin J Pain. 2008 Sep;24(7):568-71. doi: 10.1097/AJP.0b013e31816cdb20.

    PMID: 18716494BACKGROUND

  • White PF, Way WL, Trevor AJ. Ketamine--its pharmacology and therapeutic uses. Anesthesiology. 1982 Feb;56(2):119-36. doi: 10.1097/00000542-198202000-00007. No abstract available.

    PMID: 6892475BACKGROUND

  • Bowdle TA, Radant AD, Cowley DS, Kharasch ED, Strassman RJ, Roy-Byrne PP. Psychedelic effects of ketamine in healthy volunteers: relationship to steady-state plasma concentrations. Anesthesiology. 1998 Jan;88(1):82-8. doi: 10.1097/00000542-199801000-00015.

    PMID: 9447860BACKGROUND

  • Deng XM, Xiao WJ, Luo MP, Tang GZ, Xu KL. The use of midazolam and small-dose ketamine for sedation and analgesia during local anesthesia. Anesth Analg. 2001 Nov;93(5):1174-7. doi: 10.1097/00000539-200111000-00023.

    PMID: 11682390BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Sodium ChlorideKetamine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Limitations and Caveats

Study was terminated early.

Results Point of Contact

Title
Shireen Ahmad, M.D.
Organization
Northwestern University
sah704@northwestern.edu
321-472-3585

Study Officials

  • Shireen Ahmad, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2010

First Posted

April 20, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

August 7, 2015

Results First Posted

July 20, 2015

Record last verified: 2015-07

Locations

US(2)