Clinical TrialDepressive DisordersPlaceboKetamineCompleted

Impact of Ketamine On Depressive Symptoms In Patients Undergoing Lumbo-peritoneal Shunt Insertion

This Phase IV interventional trial (n=60) aims to investigate the effectiveness of intraoperative ketamine in reducing postoperative depressive symptoms in patients undergoing lumbo-peritoneal shunt insertion.

Target Enrollment
60 participants
Study Type
Phase IV interventional
Design
Randomized, triple Blind

Detailed Description

Postoperative depression is a common complication that can impair recovery and quality of life; idiopathic intracranial hypertension (IIH) patients undergoing lumbo-peritoneal shunting have high rates of anxiety and depression.

A single intraoperative dose of ketamine has rapid antidepressant effects in prior human and animal studies via NMDA antagonism, increases in BDNF, and disinhibition of reward circuits, providing rationale for perioperative use to reduce postoperative depressive symptoms.

This randomised, triple-blind, parallel Phase IV trial will compare intraoperative ketamine (50 ml at 1 mg/ml; total 50 mg) versus 50 ml normal saline in 60 patients undergoing lumbo-peritoneal shunt insertion, assessing depressive symptoms postoperatively.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Saline

inactive

50-ml normal saline (placebo comparator).

Interventions

  • Placebo50 ml
    via IV• single dose• 1 doses total

    50 ml normal saline intraoperative placebo.

Ketamine

active comparator

Ketamine 1 mg/ml, 50 ml (total 50 mg) intraoperative infusion.

Interventions

  • Ketamine50 mg
    via IV• single dose• 1 doses total

    50 ml at 1 mg/ml (total 50 mg); intraoperative infusion; other name 'katalar'.

Participants

Ages
20 – 44
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • patients of both sex
  • with an age range from 20 to 44 years old
  • having moderate to severe depressive symptoms
  • an expected hospital stay of no less than 7 days

Exclusion Criteria

  • Exclusion Criteria:
  • history of epilepsy
  • major depressive disorder patients
  • drug abuse
  • history of allergy to the research drug
  • heart rate > 120 beats per minute
  • systolic blood pressure > 180 mmHg
  • heart failure
  • renal or liver dysfunction
  • patients who cannot cooperate to complete psychiatric assessments
  • pregnant or breast-feeding women
  • patients who refuse to sign informed consent.

Study Details

  • Status
    Completed
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment60 participants
  • Timeline
    Start: 2023-09-29
    End: 2024-04-01
  • Compounds
    PlaceboKetamine
  • Topic
    Depressive Disorders

Locations

Banha faculity of medicine — Banhā, Elqalyoubea, Egypt

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