- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07135154
- Original Trial
Postoperative Opioid Consumption in Gastric Sleeve Surgery (POCiGSS)
Comparison of Balanced Anesthesia Protocols in Gastric Sleeve Surgery in Terms of Postoperative Opioid Consumption
Study Overview
Status
Conditions
Detailed Description
During gastric sleeve surgery under general anesthesia, various drugs are administered intraoperatively to induce loss of consciousness, immobility, and pain relief (analgesia). Opioids are the most commonly used analgesics. However, the response to opioids varies widely, and their use is associated with significant side effects. In balanced general anesthesia, in addition to opioid medications, hypnotics, NMDA antagonists (ketamine, magnesium sulfate), sodium channel blockers (local anesthetics), anti-inflammatory drugs (NSAIDs, dexamethasone), and alpha-2 agonists (dexmedetomidine, clonidine) may be used. One of the components of ERAS (Enhanced Recovery After Surgery) protocols, which aim to reduce metabolic stress developing in response to surgery and promote rapid recovery after surgery, is to provide effective postoperative analgesia while using opioids as little as possible. These different anesthesia approaches may offer options for surgery.
The addition of ketamine to anesthesia induction and maintenance may affect postoperative opioid consumption. Adding ketamine to anesthesia induction and maintenance may affect postoperative opioid consumption. Reducing opioid consumption can prevent opioid-related side effects such as nausea, constipation, and itching.
Opioid-related side effects such as nausea, constipation, and itching can be prevented by reducing opioid consumption.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Balıkesir, Turkey (Türkiye)
- Balıkesir University Health Practice and Research Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients who have undergone gastric sleeve surgery Patients with mild systemic disease Patients with severe systemic disease that does not affect daily activities
Exclusion Criteria:
Those with data loss in their files Those who do not use patient-controlled analgesia devices Patients who did not undergo standard anesthesia protocol
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Fentanyl
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Ketamine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Morphine Equivalent Opioid Consumption
Time Frame: 24 hours
|
A comparison was made based on the equivalent doses of opioid analgesic drugs used in both groups relative to morphine.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain
Time Frame: 24 hours
|
Postoperative pain is assessed using a numerical pain scale.
The Numerical Pain Rating Scale (NRS) was used in the study.
NRS pain scores range from 0 (no pain) to 10 (most severe pain)
|
24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- POCiGSS-2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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