CLINICAL TRIAL TO EVALUATE THE EFICACY OF DEXAMETHASONE VERSUS METHILPREDNISOLONE IN THE PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING IN NOT UNGENT LAPAROSCOPY CHOLECISTECTOMY

ONE CENTRE, DOUBLE BLIND, ONE CENTRE, RANDOMIZED CLINICAL TRIAL, IN TWO PARALLEL GROUPS TO EVALUATE THE EFICACY IN THE PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING OF DEXAMETHASONE VERSUS METHILPREDNISOLONE IN NOT URGENT LAPAROSCOPIC CHOLECYSTECTOMY

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002428-34-ES

Enrollment

314

Registered

2019-07-04

Start date

2019-09-27

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative nausea and vomiting after not urgent laparoscopic cholecystectomy MedDRA version: 20.0 Level: LLT Classification code 10036901 Term: Prophylaxis against postoperative nausea and vomiting System Organ Class: 100000004865

Interventions

Trade Name: Fortecortin Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: DEXAMETHASONE CAS Number: C22H29FO5 Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients over 18 years old, candidates to laparoscopic cholecystectomy. The patients must be well informed of the study and must voluntary accept to colaborate, obteining his/her consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: - Patients whith any allergy or intolerance to any of the drugs used in the study - Patients whith medical history of postoperative nausea and vomiting or motion sickness - Pstient who refuse to participate in the study - Patients with personal or familiar history of malignant hypertermia - Pacients under 18 yeras old. - Pacients with chronic trestment with opioids, antiemetic drugs or corticoids - Pacients who have taken psicoactive drugs or antihistamine medicines the 24 hours before the surgery - Pacients anable to give informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the trial is to compare the eficacy of dexamethasone vs. methylprednisolone in the prevention of postoperative nausea and vomiting the firt 24 hours after nor urgent laparoscopic cholecistectomy; Secondary Objective: Secondary objetives are the follow: To know the incidence of postoperative nausea and vomiting in the first two hours after surgery and from hour two to hour 24 To investigate diferencies in postopertive pain during the first 24 hours after surgery To measure and compare glucose levels in both groups at hour 2 and 24 after surgery To know rates of surgical site infection during hospital stay Grade of patient satisfaction related to nausea and vomiting in the first 24 hours after surgery ;Primary end point(s): At least 14% decrease in postoperative nausea and vomiting in the group who recive methylprednisole versus dexametasone;Timepoint(s) of evaluation of this end point: First 24 hours after surgery divided in the first 2 hours and from hour 2 to 24	—

Measure

Time frame

Main Objective: The main objective of the trial is to compare the eficacy of dexamethasone vs. methylprednisolone in the prevention of postoperative nausea and vomiting the firt 24 hours after nor urgent laparoscopic cholecistectomy; Secondary Objective: Secondary objetives are the follow: To know the incidence of postoperative nausea and vomiting in the first two hours after surgery and from hour two to hour 24 To investigate diferencies in postopertive pain during the first 24 hours after surgery To measure and compare glucose levels in both groups at hour 2 and 24 after surgery To know rates of surgical site infection during hospital stay Grade of patient satisfaction related to nausea and vomiting in the first 24 hours after surgery ;Primary end point(s): At least 14% decrease in postoperative nausea and vomiting in the group who recive methylprednisole versus dexametasone;Timepoint(s) of evaluation of this end point: First 24 hours after surgery divided in the first 2 hours and from hour 2 to 24

—

Secondary

Measure	Time frame
Secondary end point(s): Reduction in pain visual analogue scale of at least 2 points No differences in surgical site infection rates No differences in glucose levels ;Timepoint(s) of evaluation of this end point: First 24 hours after surgery	—

Countries

Spain

Contacts

Public ContactServicio de Anestesia y Reanimación

HOSPITAL CLINICO SAN CARLOS

+34913303040

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026