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

Depression, Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06060210
• Other study ID #: RC 12-9-2023
• Status: Recruiting
• Phase: Phase 4
• Start date: September 29, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: November 2023
• Source: Benha University
• Contact: Fatma Ah Abdelfatah, MD
• Phone: 01027011148
• Email: drfatmaahmed86[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety

Intervention

Drug:
• normal Saline
50-ml Saline
• Ketamine
50-ml volumes, and the ketamine concentration is 1 mg/ml

Locations

Country	Name	City	State
Egypt	Banha faculity of medicine	Banha	Elqalyoubea

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The remission rate	defined as an absolute value of MADRS score of no more than 10	at 1, 2, 5, and 7 days after the administration of ketamine.
Secondary	The incidence of severe pain	From 0 to 10 (0 no pain , 10 very sever pain)	within the first 48 hours postoperatively
Secondary	The quality of life	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