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NCT Number: NCT07469332

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location contact

Şemsi Mustafa AKSOY, Study Director

CONTACT

[email protected]

00905056212081

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline (0.9% NaCl)

Other

Intravenous normal saline 4 mL administered intraoperatively to S group

TAP Block

Procedure

Oblique subcostal TAP block is administered to all groups

moderate dose Dexamethasone

Drug

Intravenous dexamethasone administered intraoperatively at 0.1 mg/kg (D1)

High dose dexamethasone

Drug

Intravenous dexamethasone administered intraoperatively at 0.2 mg/kg (D2; maximum 20 mg).

Primary outcomes

  1. Postoperative Nausea and Vomiting (PONV)

    Time frame: 30 minutes, 1 hour, 2 hours, 4 hours, 12 hours, and 18 hours postoperatively

  2. CRP

    Time frame: preoperative and up to 18 hours postoperatively

  3. Quality of Recovery (QoR-15 Score)

    Time frame: 18 hours after surgery

  4. wbc

    Time frame: preoperative and up to 18 hours postoperatively

Secondary outcomes

  1. Postoperative Pain Intensity (VAS)

    Time frame: 30 minutes, 1 hour, 2 hours, 4 hours, 12 hours, and 18 hours postoperatively

  2. Intraoperative Remifentanil Consumption

    Time frame: Intraoperative period

  3. Postoperative Opioid Consumption

    Time frame: Up to 18 hours postoperatively

  4. Rescue Analgesic Requirement

    Time frame: Up to 18 hours postoperatively

  5. Shoulder Pain

    Time frame: Up to 18 hours postoperatively

    Postoperative Shoulder Pain assessed by Visual Analog Scale (VAS)

  6. Adverse Events

    Time frame: Intraoperative and up to 10 days postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

GÜL ŞİRİN KOÇ, MD

CONTACT

[email protected]

00905057779798

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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