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

NCT06060210 | Completed Phase 4

• 1 other identifier: RC 12-9-2023
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Depression, Anxiety

Keywords

ketamine; perioperative depression; lumboperitoneal shunt

Outcome Measures

Primary Outcomes (1)

• the rate of response to treating postoperative depression

  defined as a relative reduction of more than 50% from the baseline 10-item MADRS score

  at 3 postoperative days

Secondary Outcomes (3)

• The remission rate

  at 1 and 3 days after the administration of ketamine.

• The incidence of severe pain

  within the first 48 hours postoperatively

• The quality of life

  within 7 days postoperatively

Study Arms (2)

Group A

PLACEBO COMPARATOR

50-ml volume of normal saline

Drug: normal Saline

Group B

ACTIVE COMPARATOR

50-ml volumes, and the ketamine concentration is 1 mg/ml

Drug: Ketamine

Interventions

Ketamine DRUG

50-ml volumes, and the ketamine concentration is 1 mg/ml

Also known as: katalar

Group B

normal Saline DRUG

50-ml Saline

Group A

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Banha faculity of medicine

Banhā, Elqalyoubea, 13511, Egypt

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Saline Solution; Ketamine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Fatma Ah Abdelfatah, MD

  banha faculity of medicine

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: September 24, 2023
• First Posted: September 29, 2023
• Study Start: October 29, 2023
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 8, 2026

Record last verified: 2024-12

Locations

EG (1)