Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
90 participants
INTERVENTIONAL
2021-06-15
2026-02-28
Brief Summary
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* Furthermore, usage of ketamine both as a pre and post-operative pain management is well established. Ketamine can be used solely or in combination with other co-adjuvant drugs, increasing their efficacy. Many therapeutic properties of ketamine have been attributed to its antagonism mechanism to N-Methyl-D-aspartate receptors.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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- GROUP (I): 30 patients
bupivacaine(intraperitoneally) and ketamine (intraperitoneally)
1. 40 ml volume of bupivacaine 0.25% + ketamine 0.5 mg/kg distributed as 30 ml intraperitoneally and 10 ml as port site infiltration
2. 10 ml normal saline 0.9% will be given intravenous.
- GROUP (II): 30 patients
bupivacaine(intraperitoneally) and ketamine (intravenously)
1. 40 ml volume of bupivacaine 0.25% only distributed as 30 ml intraperitoneally and 10 ml as port site infiltration
2. 10 ml volume of ketamine 0.5 mg/kg intravenously will be given after delivering the gastric sleeve and before start closure of port sites.
- GROUP (III) (Control): 30 patients
bupivacaine(intraperitoneally)
1. 40 ml volume of bupivacaine 0.25% only distributed as 30 ml intraperitoneally and 10 ml as port site infiltration
2. 10 ml normal saline 0.9% will be given intravenous.
Interventions
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bupivacaine(intraperitoneally) and ketamine (intraperitoneally)
1. 40 ml volume of bupivacaine 0.25% + ketamine 0.5 mg/kg distributed as 30 ml intraperitoneally and 10 ml as port site infiltration
2. 10 ml normal saline 0.9% will be given intravenous.
bupivacaine(intraperitoneally) and ketamine (intravenously)
1. 40 ml volume of bupivacaine 0.25% only distributed as 30 ml intraperitoneally and 10 ml as port site infiltration
2. 10 ml volume of ketamine 0.5 mg/kg intravenously will be given after delivering the gastric sleeve and before start closure of port sites.
bupivacaine(intraperitoneally)
1. 40 ml volume of bupivacaine 0.25% only distributed as 30 ml intraperitoneally and 10 ml as port site infiltration
2. 10 ml normal saline 0.9% will be given intravenous.
Eligibility Criteria
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Inclusion Criteria
* Either medically free or with well controlled hypertension and/or diabetes.
Exclusion Criteria
* BMI \> 60 kg/m2.
* Age less than 21 years.
* Patients with severe systemic disease which is not life-threatening.
* Patients on antipsychotics, antidepressants and/or corticosteroids.
* Patients with history of obstructive sleep apnea.
* Allergic reaction to any of the study medications.
21 Years
60 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Ibrahim Mamdouh Esmat
Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.
Locations
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Ain-Shams University Hospitals
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FMASU MD 87/ 2021
Identifier Type: -
Identifier Source: org_study_id
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