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The study aimed to compare balanced anesthesia protocols using only opioids as analgesics during induction in gastric sleeve surgery with protocols using opioids and ketamine together in terms of anesthesia management, opioid side effects, and postoperative analgesia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl | Fentanyl | ||
| Ketamine | Ketamine |
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| Measure | Description | Time Frame |
|---|---|---|
| Morphine Equivalent Opioid Consumption | A comparison was made based on the equivalent doses of opioid analgesic drugs used in both groups relative to morphine. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain | 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 |
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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
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Those who have undergone gastric sleeve surgery in the general surgery operating room at Balıkesir University Hospital
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Balıkesir University Health Practice and Research Hospital | Balıkesir | Turkey (Türkiye) |
Of the patient records evaluated for compliance (n=205), 109 did not comply with standard protocols or had incomplete data as follows: 55 patients did not receive patient-controlled analgesia for postoperative pain management, 15 patients did not receive intravenous lidocaine (1.5 mg/kg ideal body weight), 33 patients did not receive intravenous fentanyl (1.0 µg/kg total body weight), and 6 patients lacked records of postoperative analgesic administration.
96 Number of study patients
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| ID | Title | Description |
|---|---|---|
| FG000 | Fentanyl Group | The control group consisted of patients who underwent surgery using standard balanced anesthesia and fentanyl. |
| FG001 | Ketamine Group | The ketamine group consisted of patients who received ketamine infusion during surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fentanyl Group | The control group consisted of patients who underwent surgery using standard balanced anesthesia and fentanyl. |
| BG001 | Ketamine Group | The ketamine group consisted of patients who received ketamine infusion during surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Morphine Equivalent Opioid Consumption | A comparison was made based on the equivalent doses of opioid analgesic drugs used in both groups relative to morphine. | Posted | Median | Inter-Quartile Range | miligram | 24 hours |
|
up to 12 weeks
There are participants at risk of death for all reasons.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fentanyl | The control group consisted of patients who underwent surgery using standard balanced anesthesia and fentanyl. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| serkan uckun | University of Balikesir | 535 370 1164 | serkan.uckun@balikesir.edu.tr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: POCiGSS_Study Protocol and Statistical Analysis Plan | May 16, 2025 | Apr 1, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| weight | Mean | Standard Deviation | kg |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Postoperative Pain | 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) | Posted | Median | Inter-Quartile Range | scores on a scale | 24 hours |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Ketamine | The ketamine group consisted of patients who received ketamine infusion during surgery. | 0 | 47 | 0 | 47 | 0 | 47 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |