Obesity &Amp; OverweightPOCiGSSNCT07135154
Postoperative Opioid Consumption in Gastric Sleeve Surgery
An observational study of Obesity &Amp; Overweight and General Anesthetic, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity &Amp; Overweight, General Anesthetic, Ketamine
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2024to 27 Feb 2026
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those who have undergone gastric sleeve surgery in the general surgery operating room at Balıkesir University Hospital
Who may be able to join
- Patients who have undergone gastric sleeve surgery Patients with mild systemic disease Patients with severe systemic disease that does not affect daily activities
Who cannot join
- Those with data loss in their files Those who do not use patient-controlled analgesia devices Patients who did not undergo standard anesthesia protocol
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Balıkesir University Health Practice and Research Hospital
Balıkesir
About this study
Official title: Comparison of Balanced Anesthesia Protocols in Gastric Sleeve Surgery in Terms of Postoperative Opioid Consumption
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.
Read the 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.
- Conditions
- Obesity &Amp; Overweight, General Anesthetic, Ketamine
- Keywords
- obesity, general anesthesia, ketamine
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl | Fentanyl | |
| Ketamine | Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Equivalent Opioid Consumption
A comparison was made based on the equivalent doses of opioid analgesic drugs used in both groups relative to morphine.
Measured: 24 hours
Secondary outcomes (1)
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)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start3 Jun 2024
- Primary completion29 Mar 2025
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obesity &Amp; OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Uckun, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135154
- Sponsor's protocol ID
- POCiGSS-2025
- Acronym
- POCiGSS
- Status last verified
- Feb 2026
- First submitted
- 13 Aug 2025
- Last updated
- 14 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Balanced Anesthesia Protocols in Gastric Sleeve Surgery in Terms of Postoperative Opioid Consumption
- ClinicalTrials.gov ID
- NCT07135154
- Acronym / sponsor ID
- POCiGSS / POCiGSS-2025
- Conditions
- Obesity &Amp; Overweight, General Anesthetic, Ketamine
- Keywords
- obesity, general anesthesia, ketamine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 29 Mar 2025 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 21 Aug 2025 (actual)
- Results
- Posted 14 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl | – | –Fentanyl |
| Ketamine | – | –Ketamine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those who have undergone gastric sleeve surgery in the general surgery operating room at Balıkesir University Hospital
Key inclusion criteria (1 listed)
- Patients who have undergone gastric sleeve surgery Patients with mild systemic disease Patients with severe systemic disease that does not affect daily activities
Key exclusion criteria (1 listed)
- Those with data loss in their files Those who do not use patient-controlled analgesia devices Patients who did not undergo standard anesthesia protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Postoperative Pain
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity &Amp; Overweight and General Anesthetic, run by Balikesir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine Equivalent Opioid Consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.