Postoperative RecoveryNCT07469332
Comparison of the Effects of Moderate- and High-Dose Glucocorticoids on Postoperative Recovery
A study testing Saline (0.9% NaCl), TAP Block and moderate dose Dexamethasone in people with Postoperative Recovery and PONV, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic cholecystectomy is a commonly performed minimally invasive surgical procedure; however, postoperative pain, nausea, and delayed recovery remain clinically relevant problems. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Recovery, PONV
- What is being tested?
- Saline (0.9% NaCl), TAP Block and moderate dose Dexamethasone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2026to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age between 18 and 65 years
- ASA physical status I-II
- Scheduled for elective laparoscopic cholecystectomy
- Undergoing general anesthesia
- Ability to provide written informed consent
Who cannot join
- Patients younger than 18 years or older than 65 years
- Known allergy to dexamethasone
- ASA physical status III or higher
- Surgical procedures lasting longer than 120 minutes
- Emergency surgeries
- Pregnant or breastfeeding patients
Show all 26Show fewer
- Patients with coagulopathy or receiving anticoagulant therapy
- Known allergy to local anesthetics
- Localized infection at the injection site
- Inflammatory bowel disease
- Autoimmune diseses
- Chronic pain conditions
- Ocular herpes simplex infection
- Cushing's disease
- Myasthenia gravis
- Anticipated poor compliance with the study protocol
- Vaccination within the last 14 days
- Use of systemic glucocorticoids or immunosuppressive drugs
- İmpaired renal function (GFR < 30 mL/min)
- Liver cirrhosis
- Congestive heart failure
- Peripheral nerve disorders
- Elective laparoscopic cholecystectomy due to malignancy
- Conversion to open surgery during the operation
- Epilepsy
- Body mass index (BMI) > 30 kg/m²
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation
Ankara, Çankaya, 06800
Şemsi Mustafa AKSOY, Study Director, 00905056212081, drsmaksoy@gmail.com
About this study
Official title: Comparison of the Effects of Moderate- and High-Dose Glucocorticoid Administration on Postoperative Recovery: A Prospective Randomized Controlled Trial
Laparoscopic cholecystectomy is a commonly performed minimally invasive surgical procedure; however, postoperative pain, nausea, and delayed recovery remain clinically relevant problems. Glucocorticoids such as dexamethasone are widely used in perioperative care for the prevention of postoperative nausea and vomiting and as part of multimodal analgesia strategies.
This prospective randomized controlled trial aims to compare the effects of moderate- and high-dose intravenous dexamethasone administered intraoperatively on postoperative recovery in patients undergoing elective laparoscopic cholecystectomy. The primary outcomes include postoperative nausea and vomiting, inflammatory markers (CRP and WBC), and Quality of Recovery-15 (QoR-15) scores. Secondary outcomes include postoperative pain scores, intraoperative remifentanil consumption, postoperative opioid consumption, and adverse events.
Read the detailed description
Laparoscopic cholecystectomy is one of the most commonly performed minimally invasive surgical procedures worldwide. Although it is associated with shorter hospital stay and faster recovery compared with open surgery, patients frequently experience postoperative pain, nausea, and delayed functional recovery. Effective perioperative strategies aimed at improving recovery and reducing postoperative complications remain an important component of enhanced recovery protocols.
Glucocorticoids, particularly dexamethasone, are widely used in perioperative care due to their anti-inflammatory, antiemetic, and analgesia-sparing properties. Perioperative dexamethasone administration has been shown to reduce postoperative nausea and vomiting (PONV) and may contribute to improved pain control and overall recovery. However, the optimal dose of dexamethasone for maximizing recovery outcomes while maintaining safety remains unclear.
This prospective randomized controlled study is designed to evaluate whether higher doses of intraoperative dexamethasone provide additional benefits in postoperative recovery compared with moderate doses or placebo in patients undergoing elective laparoscopic cholecystectomy. Patients undergoing elective surgery will be randomly assigned to receive either moderate-dose dexamethasone, high-dose dexamethasone, or placebo as part of perioperative management.
All patients will receive standardized anesthesia management and multimodal analgesia according to institutional practice. Postoperative recovery will be evaluated using patient-reported recovery quality scores, inflammatory markers, and commonly assessed clinical outcomes including postoperative nausea and vomiting, pain intensity, and analgesic requirements.
The findings of this study may help clarify the dose-response relationship of perioperative dexamethasone and provide evidence to guide optimal dosing strategies aimed at improving postoperative recovery after laparoscopic cholecystectomy.
- Conditions
- Postoperative Recovery, PONV
- Being tested
- Saline (0.9% NaCl), TAP Block, moderate dose Dexamethasone, High dose dexamethasone
- Keywords
- Postoperative Recovery, Postoperative Pain, dexamethasone, Postoperative Nausea and Vomiting, high dose, moderate dose
- Medical subject headings
- Postoperative Nausea and Vomiting, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline (0.9% NaCl)Other
Intravenous normal saline 4 mL administered intraoperatively to S group
TAP BlockProcedure or surgery
Oblique subcostal TAP block is administered to all groups
moderate dose DexamethasoneDrug
Intravenous dexamethasone administered intraoperatively at 0.1 mg/kg (D1)
High dose dexamethasoneDrug
Intravenous dexamethasone administered intraoperatively at 0.2 mg/kg (D2; maximum 20 mg).
| Study group | Role | What they receive |
|---|---|---|
| D1: Moderate-dose dexamethasone | Experimental | Not described Receives: Procedure: TAP Block; Drug: moderate dose Dexamethasone |
| D2: High-dose dexamethasone | Experimental | Not described Receives: Procedure: TAP Block; Drug: High dose dexamethasone |
| S: Control (normal saline) | Placebo comparator | Not described Receives: Other: Saline (0.9% NaCl); Procedure: TAP Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Nausea and Vomiting (PONV)
Measured: 30 minutes, 1 hour, 2 hours, 4 hours, 12 hours, and 18 hours postoperatively
CRP
Measured: preoperative and up to 18 hours postoperatively
Quality of Recovery (QoR-15 Score)
Measured: 18 hours after surgery
wbc
Measured: preoperative and up to 18 hours postoperatively
Secondary outcomes (6)
Postoperative Pain Intensity (VAS)
Measured: 30 minutes, 1 hour, 2 hours, 4 hours, 12 hours, and 18 hours postoperatively
Intraoperative Remifentanil Consumption
Measured: Intraoperative period
Postoperative Opioid Consumption
Measured: Up to 18 hours postoperatively
Rescue Analgesic Requirement
Measured: Up to 18 hours postoperatively
Shoulder Pain
Postoperative Shoulder Pain assessed by Visual Analog Scale (VAS)
Measured: Up to 18 hours postoperatively
Adverse Events
Measured: Intraoperative and up to 10 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start30 Mar 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative RecoveryStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469332
- Sponsor's protocol ID
- E2-25-10587
- Status last verified
- Mar 2026
- First submitted
- 21 Jan 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Moderate- and High-Dose Glucocorticoid Administration on Postoperative Recovery: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07469332
- Acronym / sponsor ID
- E2-25-10587
- Conditions
- Postoperative Recovery, PONV
- Keywords
- Postoperative Recovery, Postoperative Pain, dexamethasone, Postoperative Nausea and Vomiting, high dose, moderate dose
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laparoscopic cholecystectomy is a commonly performed minimally invasive surgical procedure; however, postoperative pain, nausea, and delayed recovery remain clinically relevant problems. Glucocorticoids such as dexamethasone are widely used in perioperative care for the prevention of postoperative nausea and vomiting and as part of multimodal analgesia strategies.
This prospective randomized controlled trial aims to compare the effects of moderate- and high-dose intravenous dexamethasone administered intraoperatively on postoperative recovery in patients undergoing elective laparoscopic cholecystectomy. The primary outcomes include postoperative nausea and vomiting, inflammatory markers (CRP and WBC), and Quality of Recovery-15 (QoR-15) scores. Secondary outcomes include postoperative pain scores, intraoperative remifentanil consumption, postoperative opioid consumption, and adverse events.
Detailed description
Laparoscopic cholecystectomy is one of the most commonly performed minimally invasive surgical procedures worldwide. Although it is associated with shorter hospital stay and faster recovery compared with open surgery, patients frequently experience postoperative pain, nausea, and delayed functional recovery. Effective perioperative strategies aimed at improving recovery and reducing postoperative complications remain an important component of enhanced recovery protocols.
Glucocorticoids, particularly dexamethasone, are widely used in perioperative care due to their anti-inflammatory, antiemetic, and analgesia-sparing properties. Perioperative dexamethasone administration has been shown to reduce postoperative nausea and vomiting (PONV) and may contribute to improved pain control and overall recovery. However, the optimal dose of dexamethasone for maximizing recovery outcomes while maintaining safety remains unclear.
This prospective randomized controlled study is designed to evaluate whether higher doses of intraoperative dexamethasone provide additional benefits in postoperative recovery compared with moderate doses or placebo in patients undergoing elective laparoscopic cholecystectomy. Patients undergoing elective surgery will be randomly assigned to receive either moderate-dose dexamethasone, high-dose dexamethasone, or placebo as part of perioperative management.
All patients will receive standardized anesthesia management and multimodal analgesia according to institutional practice. Postoperative recovery will be evaluated using patient-reported recovery quality scores, inflammatory markers, and commonly assessed clinical outcomes including postoperative nausea and vomiting, pain intensity, and analgesic requirements.
The findings of this study may help clarify the dose-response relationship of perioperative dexamethasone and provide evidence to guide optimal dosing strategies aimed at improving postoperative recovery after laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| D1: Moderate-dose dexamethasone | Experimental | Procedure: TAP Block, Drug: moderate dose Dexamethasone |
| D2: High-dose dexamethasone | Experimental | Procedure: TAP Block, Drug: High dose dexamethasone |
| S: Control (normal saline) | Placebo comparator | Other: Saline (0.9% NaCl), Procedure: TAP Block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years
- ASA physical status I-II
- Scheduled for elective laparoscopic cholecystectomy
- Undergoing general anesthesia
- Ability to provide written informed consent
Key exclusion criteria (26 listed)
- Patients younger than 18 years or older than 65 years
- Known allergy to dexamethasone
- ASA physical status III or higher
- Surgical procedures lasting longer than 120 minutes
- Emergency surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline (0.9% NaCl)Intravenous normal saline 4 mL administered intraoperatively to S group | Other | S: Control (normal saline) |
| TAP BlockOblique subcostal TAP block is administered to all groups | Procedure or surgery | D1: Moderate-dose dexamethasone, D2: High-dose dexamethasone, S: Control (normal saline) |
| moderate dose DexamethasoneIntravenous dexamethasone administered intraoperatively at 0.1 mg/kg (D1) | Drug | D1: Moderate-dose dexamethasone |
| High dose dexamethasoneIntravenous dexamethasone administered intraoperatively at 0.2 mg/kg (D2; maximum 20 mg). | Drug | D2: High-dose dexamethasone |
Primary outcome
Postoperative Nausea and Vomiting (PONV)
Time frame: 30 minutes, 1 hour, 2 hours, 4 hours, 12 hours, and 18 hours postoperatively
CRP
Time frame: preoperative and up to 18 hours postoperatively
Quality of Recovery (QoR-15 Score)
Time frame: 18 hours after surgery
wbc
Time frame: preoperative and up to 18 hours postoperatively
6 secondary outcomes
Postoperative Pain Intensity (VAS)
Time frame: 30 minutes, 1 hour, 2 hours, 4 hours, 12 hours, and 18 hours postoperatively
Intraoperative Remifentanil Consumption
Time frame: Intraoperative period
Postoperative Opioid Consumption
Time frame: Up to 18 hours postoperatively
Rescue Analgesic Requirement
Time frame: Up to 18 hours postoperatively
Shoulder Pain
Time frame: Up to 18 hours postoperatively
Adverse Events
Time frame: Intraoperative and up to 10 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline (0.9% NaCl), TAP Block and moderate dose Dexamethasone in people with Postoperative Recovery and PONV, run by Ankara City Hospital Bilkent 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 5 inclusion and 26 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: opening soon, as of the sponsor's last update on 13 Mar 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GÜL ŞİRİN KOÇ, MD (00905057779798, glcintosun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Nausea and Vomiting (PONV) (time frame: 30 minutes, 1 hour, 2 hours, 4 hours, 12 hours, and 18 hours postoperatively). The study lists 4 primary outcomes in all. 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 13 Mar 2026.