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

NCT07469332 | Not Yet Recruiting

• 1 other identifier: E2-25-10587
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Recovery; PONV

Keywords

Postoperative Recovery; Postoperative Pain; dexamethasone; Postoperative Nausea and Vomiting; high dose; moderate dose

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• 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

  Up to 18 hours postoperatively

Study Arms (3)

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

Interventions

Saline (0.9% NaCl) OTHER

Intravenous normal saline 4 mL administered intraoperatively to S group

S: Control (normal saline)

TAP Block PROCEDURE

Oblique subcostal TAP block is administered to all groups

D1: Moderate-dose dexamethasone; D2: High-dose dexamethasone; S: Control (normal saline)

moderate dose Dexamethasone DRUG

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

D1: Moderate-dose dexamethasone

High dose dexamethasone DRUG

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

D2: High-dose dexamethasone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pain, Postoperative

Interventions

Sodium Chloride; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

GÜL ŞİRİN KOÇ, MD

CONTACT

00905057779798; glcintosun@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: March 13, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)