NCT03666494

Brief Summary

Ketamine hydrochloride, an anesthetic medication, has been demonstrated to acutely and rapidly improve depressive symptoms but not yet been adequately studied for this effect when used as part of a general anesthetic for surgery. This proposed single-centre, double-blinded, randomized clinical trial of adult patients with depression presenting for gynecologic surgery would compare severity of depressive symptoms between patients receiving and not receiving ketamine as part of their general anesthetic.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2018

Shorter than P25 for phase_4

Status
unknown

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

First Submitted

Initial submission to the registry

August 15, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 13, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

August 15, 2018

Last Update Submit

September 12, 2018

Conditions

KetamineDepressionAnesthesia

Outcome Measures

Primary Outcomes (4)

  • Depression Severity

    Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and \>34 is severe depression.

    At time of discharge from post-anesthetic care unit, until 3 hours post operatvie

  • Depression Severity

    Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and \>34 is severe depression.

    72 hours post-operative

  • Depression Severity

    Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and \>34 is severe depression.

    7-days post-operative

  • Depression Severity

    Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and \>34 is severe depression.

    30-days post-operative

Secondary Outcomes (10)

  • Pain Score

    Pre-operatively

  • Pain Score

    Upon discharge from PACU, up to 3 hours postoperative

  • Pain Score

    72 hours post-opertaive

  • Pain Score

    7-days post-op

  • Pain Score

    30-days post-op

  • +5 more secondary outcomes

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

As part of the patient's anesthetic induction, they will receive propofol and fentanyl.

Drug: PropofolDrug: Fentanyl

Ketamine Arm

ACTIVE COMPARATOR

As part of the patient's anesthetic induction, they will receive propofol, fentanyl, as well as ketamine hydrochloride.

Drug: Ketamine HydrochlorideDrug: PropofolDrug: Fentanyl

Interventions

Ketamine HydrochlorideDRUG

As part of anesthetic induction, the addition of ketamine hydrochloride 0.5mg/kg.

Ketamine Arm
PropofolDRUG

As part of the patient's anesthetic induction, they will receive propofol.

Control ArmKetamine Arm
FentanylDRUG

As part of the patient's anesthetic induction, they will receive fentanyl.

Control ArmKetamine Arm

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of major depressive disorder
  • Presentation for gynecologic surgery requiring a general anesthetic

You may not qualify if:

  • Marked co-morbid cardiovascular disease
  • Marked co-morbid respiratory disease
  • History of intracranial hypertension
  • History of seizures
  • ASA Physical Status Classification IV or greater
  • History of psychosis
  • Current pregnancy
  • Contraindication to ketamine administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Kudoh A, Takahira Y, Katagai H, Takazawa T. Small-dose ketamine improves the postoperative state of depressed patients. Anesth Analg. 2002 Jul;95(1):114-8, table of contents. doi: 10.1097/00000539-200207000-00020.

    PMID: 12088953BACKGROUND

  • McGirr A, Berlim MT, Bond DJ, Fleck MP, Yatham LN, Lam RW. A systematic review and meta-analysis of randomized, double-blind, placebo-controlled trials of ketamine in the rapid treatment of major depressive episodes. Psychol Med. 2015 Mar;45(4):693-704. doi: 10.1017/S0033291714001603. Epub 2014 Jul 10.

    PMID: 25010396BACKGROUND

  • Lee EE, Della Selva MP, Liu A, Himelhoch S. Ketamine as a novel treatment for major depressive disorder and bipolar depression: a systematic review and quantitative meta-analysis. Gen Hosp Psychiatry. 2015 Mar-Apr;37(2):178-84. doi: 10.1016/j.genhosppsych.2015.01.003. Epub 2015 Jan 15.

    PMID: 25698228BACKGROUND

  • Fond G, Loundou A, Rabu C, Macgregor A, Lancon C, Brittner M, Micoulaud-Franchi JA, Richieri R, Courtet P, Abbar M, Roger M, Leboyer M, Boyer L. Ketamine administration in depressive disorders: a systematic review and meta-analysis. Psychopharmacology (Berl). 2014 Sep;231(18):3663-76. doi: 10.1007/s00213-014-3664-5. Epub 2014 Jul 20.

    PMID: 25038867BACKGROUND

  • Larkin GL, Beautrais AL. A preliminary naturalistic study of low-dose ketamine for depression and suicide ideation in the emergency department. Int J Neuropsychopharmacol. 2011 Sep;14(8):1127-31. doi: 10.1017/S1461145711000629. Epub 2011 May 5.

    PMID: 21557878BACKGROUND

  • Caddy C, Giaroli G, White TP, Shergill SS, Tracy DK. Ketamine as the prototype glutamatergic antidepressant: pharmacodynamic actions, and a systematic review and meta-analysis of efficacy. Ther Adv Psychopharmacol. 2014 Apr;4(2):75-99. doi: 10.1177/2045125313507739.

    PMID: 24688759BACKGROUND

  • Berman RM, Cappiello A, Anand A, Oren DA, Heninger GR, Charney DS, Krystal JH. Antidepressant effects of ketamine in depressed patients. Biol Psychiatry. 2000 Feb 15;47(4):351-4. doi: 10.1016/s0006-3223(99)00230-9.

    PMID: 10686270BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

KetaminePropofolFentanyl

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhenolsBenzene DerivativesHydrocarbons, AromaticPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jonathan Gamble, MD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Gamble, MD

CONTACT

306-655-1183j_gamble@yahoo.com

Jordon Steeg, MD

CONTACT

306-222-9782jordon.steeg@usask.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2018

First Posted

September 11, 2018

Study Start

December 1, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

September 13, 2018

Record last verified: 2018-08