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

Primary Purpose

Depression, Anxiety

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
normal Saline
Ketamine
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression, Anxiety focused on measuring ketamine, perioperative depression, lumboperitoneal shunt

Eligibility Criteria

20 Years - 44 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Banha faculity of medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Group A

Group B

Arm Description

50-ml volume of normal saline

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

Outcomes

Primary Outcome Measures

the rate of response to treating postoperative depression
defined as a relative reduction of more than 50% from the baseline 10-item MADRS score

Secondary Outcome Measures

The remission rate
defined as an absolute value of MADRS score of no more than 10
The incidence of severe pain
From 0 to 10 (0 no pain , 10 very sever pain)
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'.

Full Information

First Posted
September 24, 2023
Last Updated
September 24, 2023
Sponsor
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT06060210
Brief Title
Impact of Ketamine On Depressive Symptoms In Patients Undergoing Lumbo-peritoneal Shunt Insertion
Official Title
Impact of Ketamine On Depressive Symptoms In Patients Undergoing Lumbo-peritoneal Shunt Insertion. A Randomized Double-blind Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2023 (Anticipated)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 .
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
ketamine, perioperative depression, lumboperitoneal shunt

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Placebo Comparator
Arm Description
50-ml volume of normal saline
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
50-ml volumes, and the ketamine concentration is 1 mg/ml
Intervention Type
Drug
Intervention Name(s)
normal Saline
Intervention Description
50-ml Saline
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
katalar
Intervention Description
50-ml volumes, and the ketamine concentration is 1 mg/ml
Primary Outcome Measure Information:
Title
the rate of response to treating postoperative depression
Description
defined as a relative reduction of more than 50% from the baseline 10-item MADRS score
Time Frame
at 3 postoperative days
Secondary Outcome Measure Information:
Title
The remission rate
Description
defined as an absolute value of MADRS score of no more than 10
Time Frame
at 1, 2, 5, and 7 days after the administration of ketamine.
Title
The incidence of severe pain
Description
From 0 to 10 (0 no pain , 10 very sever pain)
Time Frame
within the first 48 hours postoperatively
Title
The quality of life
Description
a scale ranging from 100-0, where 100 is labeled 'Perfect quality of life,' and 0 is labeled 'Might as well be dead'.
Time Frame
within 7 days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma Ah Abdelfatah, MD
Phone
01027011148
Email
drfatmaahmed86@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma Ah Abdelfatah, MD
Organizational Affiliation
banha faculity of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banha faculity of medicine
City
Banha
State/Province
Elqalyoubea
ZIP/Postal Code
13511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatma Ah Abdelfataah, MD
Phone
00201027011148
Email
drfatmaahmed86@gmail.com

12. IPD Sharing Statement

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

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