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

ConditionsPostoperative RecoveryPONV
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAnkara City Hospital Bilkent

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 65 years

ASA physical status I-II

Scheduled for elective laparoscopic cholecystectomy

Undergoing general anesthesia

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Saline (0.9% NaCl)

    Other intervention

    Intravenous normal saline 4 mL administered intraoperatively to S group

  • TAP Block

    Procedure/Surgery

    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).

Treatment groups

135 Participants
are divided into 3 treatment groups
Group A: D1: Moderate-dose dexamethasoneExperimental treatment 2 interventions
Group B: D2: High-dose dexamethasoneExperimental treatment 2 interventions
Group C: S: Control (normal saline)Placebo comparator 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ankara City Hospital Bilkent

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: