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Not yet recruiting NCT07469332

Comparison of the Effects of Moderate- and High-Dose Glucocorticoids on Postoperative Recovery

No phase Interventional Postoperative Recovery PONV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Saline (0.9% NaCl), TAP Block, moderate dose Dexamethasone, High dose dexamethasone.
Who it may be relevant to
Registry conditions: Postoperative Recovery, PONV. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparison of the Effects of Moderate- and High-Dose Glucocorticoid Administration on Postoperative Recovery: A Prospective Randomized Controlled Trial

Overview

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.

Interventions

  • Other Saline (0.9% NaCl)
    Intravenous normal saline 4 mL administered intraoperatively to S group
  • Procedure TAP Block
    Oblique subcostal TAP block is administered to all groups
  • Drug moderate dose Dexamethasone
    Intravenous dexamethasone administered intraoperatively at 0.1 mg/kg (D1)
  • Drug High dose dexamethasone
    Intravenous dexamethasone administered intraoperatively at 0.2 mg/kg (D2; maximum 20 mg).

Primary outcome measures

  • 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]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation — Ankara

Identifiers

NCT: NCT07469332 · E2-25-10587

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗