Efficacy of sufentanil in urgent laparoscopic cholecystectomy: An alternative to the usual opioids for postoperative pain?

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Biomedica Galicia Sur

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Decision date (initial)

2026-06-08

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

Determine whether intraoperative administration of sufentanil using concentration-targeted continuous intravenous infusion (TCI) models is not inferior to postoperative analgesia within 24 hours after surgery (measured by EVA) in patients undergoing urgent laparoscopic cholecystectomy, compared to the administration of fentanyl according to standard clinical practice at our hospital.

Secondary objectives 8

1. Decribe the clinical and sociodemographic characteristics of the study population
2. Compere the pain intensity (EVA Scale), in the two study arms, at 1 h, 2h and 12 hours postoperative
3. Estimate the intra-group difference in intensity of pain at 1h, 2h and 12 hour postoperativa
4. Compare the total opioid dose (fentanyl or sufentanyl) used in each group measured at total micrograms
5. Compare the total opioid dose of rescue (morphine equivlent, mg) required in the first 24 postoperative hours in the two study groups
6. Compare time to first request of postoperative analgesia
7. Compare the incidence of opioid-related adverse events (nausea, vomiting, respiratory depression, pruritus) between both study groups
8. Compare the used doses of one and another drug

Conditions and MedDRA coding

Laparoscopic cholecystectomy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Age equal to or older than 18 years.
2. ASA Classification I, II or III.
3. Urgent laparoscopic cholecystectomy surgery.
4. Signing the Informed Consent.

Exclusion criteria 7

1. Known allergy to Fentanyl or Sufentanil.
2. ASA IV or V
3. Chronic opioid use, oral morphine equivalent dose >10 DEM.
4. Psychiatric or neurological pathology that prevents collaboration or use of the EVA scale.
5. Severe kidney or liver failure.
6. Moderate pulmonary pathology or home oxygen.
7. Pregnancy or breastfeeding.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Visual Analogue Scale (VAS)

Secondary endpoints 13

1. Age
2. Sex
3. Weight
4. Height
5. ASA
6. VAS at the first postoperative hour
7. VAS at the second postoperative hour
8. VAS at the 12th postoperative hour
9. Postoperative nausea or vomiting
10. Pruritus
11. Respiratory depression
12. Micrograms of opioids administered during surgery
13. Opioid use in the first 24 hours

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Biomedica Galicia Sur

Sponsor organisation

Fundacion Biomedica Galicia Sur

Address

Carretera Clara Campoamor 341, Bloque Tecnico Planta 2 Bloque Tecnico Planta 2

City

Vigo

Postcode

36213

Country

Spain

Scientific contact point

Organisation

Fundacion Biomedica Galicia Sur

Contact name

Daniel Melián Hernández

Public contact point

Organisation

Fundacion Biomedica Galicia Sur

Contact name

Daniel Melián Hernández

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications