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

January 7, 2026 updated by: Fatma Ahmed Abdel Fatah, Benha University

Impact of Ketamine On Depressive Symptoms In Patients Undergoing Lumbo-peritoneal Shunt Insertion. A Randomized Double-blind Controlled Trial.

Postoperative depression is a perioperative psychological complication that severely affects patient recovery and quality of life. In extreme cases, it may lead to suicidal behavior. Postoperative depression can be seen in various surgical operations .

High rates of anxiety and depression have been reported in cohorts of patients with IIH, though it is not clear whether there is any direct relationship. Worse outcomes in terms of disability level and symptom resolution have been observed in IIH patients who have a known co-existing psychiatric illness compared to those who do not .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postoperative depression is a perioperative psychological complication that severely affects patient recovery and quality of life. In extreme cases, it may lead to suicidal behavior. Postoperative depression can be seen in various surgical operations.

Idiopathic intracranial hypertension (IIH) is the most common cause of papilledema and is typically seen in young women with elevated body mass index. The prevalence of IIH has been increasing in recent years, in parallel with climbing rates of obesity .

High rates of anxiety and depression have been reported in cohorts of patients with IIH, though it is not clear whether there is any direct relationship. Worse outcomes in terms of disability level and symptom resolution have been observed in IIH patients who have a known co-existing psychiatric illness compared to those who do not .

The use of lumbo-peritoneal (LP) shunts has been well documented as a treatment modality for patients with idiopathic intracranial hypertension (IIH). There are a number of advantages to LP shunts when compared with other treatment modalities for IIH, such as stereotactic ventriculo-peritoneal shunts (VP) and optic nerve sheath fenestrations (ONSF). LP shunts avoid intracranial risks, such as cerebral hemorrhage, seizures, and shunt malposition.

Over the past decade, it has been provoked a single administration of ketamine elicits fast (in as little as half an hour) and sustained antidepressant effects both in human and animal models of depression. There are some potential mechanisms of antidepressant actions of ketamine. MK-801, a noncompetitive NMDA receptor antagonist, produced antidepressant-like actions in the animal model of depression . Ketamine can also increase hippocampal brain-derived neurotrophic factor levels, which may be important for producing a rapid onset of antidepressant action .A recent study found ketamine could quickly elevate mood by blocking NMDAR receptor-dependent bursting activity of the lateral habenula neurons to disinhibit downstream monoaminergic reward centers and provide a framework for developing new rapid-acting antidepressants .

Accordingly, we hypothesized that intraoperative ketamine can reduce the post operative depressive symptoms after theco-peritoneal shunt insertion.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Elqalyoubea
      • Banhā, Elqalyoubea, Egypt, 13511
        • Banha Faculity of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group A
50-ml volume of normal saline
Drug: normal Saline
50-ml Saline
Active Comparator: Group B
50-ml volumes, and the ketamine concentration is 1 mg/ml
Drug: Ketamine
50-ml volumes, and the ketamine concentration is 1 mg/ml
Other Names:
  • katalar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the rate of response to treating postoperative depression
Time Frame: at 3 postoperative days
defined as a relative reduction of more than 50% from the baseline 10-item MADRS score
at 3 postoperative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of severe pain
Time Frame: within the first 48 hours postoperatively
From 0 to 10 (0 no pain , 10 very sever pain)
within the first 48 hours postoperatively
The quality of life
Time Frame: within 7 days postoperatively
a scale ranging from 100-0, where 100 is labeled 'Perfect quality of life,' and 0 is labeled 'Might as well be dead'.
within 7 days postoperatively
The remission rate
Time Frame: at 1 and 3 days after the administration of ketamine.
defined as an absolute value of MADRS score of no more than 10
at 1 and 3 days after the administration of ketamine.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Principal Investigator: Fatma Ah Abdelfatah, MD, Banha Faculity of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2023

Primary Completion (Actual)

September 1, 2025

Study Completion (Actual)

November 1, 2025

Study Registration Dates

First Submitted

September 24, 2023

First Submitted That Met QC Criteria

September 24, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC 12-9-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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