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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: PONV; Postoperative Recovery
• Intervention / Treatment: Procedure: TAP Block; Drug: moderate dose Dexamethasone; Drug: High dose dexamethasone; Other: Saline (0.9% NaCl)

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 Type: Interventional
• Enrollment (Estimated): 135
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: GÜL ŞİRİN KOÇ, MD; Phone Number: 00905057779798; Email: glcintosun@gmail.com

Study Locations

• Turkey (Türkiye)
  • Çankaya
    • Ankara, Çankaya, Turkey (Türkiye), 06800
      • Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation
      • Contact: Şemsi Mustafa AKSOY, Study Director; Phone Number: 00905056212081; Email: drsmaksoy@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: D1: Moderate-dose dexamethasone	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)
Experimental: D2: High-dose dexamethasone	Procedure: TAP Block; Oblique subcostal TAP block is administered to all groups; Drug: High dose dexamethasone; Intravenous dexamethasone administered intraoperatively at 0.2 mg/kg (D2; maximum 20 mg).
Placebo Comparator: S: Control (normal saline)	Procedure: TAP Block; Oblique subcostal TAP block is administered to all groups; Other: Saline (0.9% NaCl); Intravenous normal saline 4 mL administered intraoperatively to S group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative Nausea and Vomiting (PONV)	30 minutes, 1 hour, 2 hours, 4 hours, 12 hours, and 18 hours postoperatively
CRP	preoperative and up to 18 hours postoperatively
Quality of Recovery (QoR-15 Score)	18 hours after surgery
wbc	preoperative and up to 18 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Intensity (VAS)		30 minutes, 1 hour, 2 hours, 4 hours, 12 hours, and 18 hours postoperatively
Intraoperative Remifentanil Consumption		Intraoperative period
Postoperative Opioid Consumption		Up to 18 hours postoperatively
Rescue Analgesic Requirement		Up to 18 hours postoperatively
Shoulder Pain	Postoperative Shoulder Pain assessed by Visual Analog Scale (VAS)	Up to 18 hours postoperatively
Adverse Events		Intraoperative and up to 10 days postoperatively

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Pain; Postoperative Nausea and Vomiting; dexamethasone; high dose; Postoperative Recovery; moderate dose
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Vomiting; Nausea; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Postoperative Nausea and Vomiting; Polycyclic Compounds; Inorganic Chemicals; Chlorine Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Sodium Compounds; Chlorides; Hydrochloric Acid; Dexamethasone; Sodium Chloride
• Other Study ID Numbers: E2-25-10587

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No