Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Temporarily halted
Participants planned
64
Countries
1
Sites
1
Obesity
To determine whether opioid-free general anesthesia, compared to opioid-based general anesthesia, reduces the frequency and intensity of postoperative nausea and vomiting in patients undergoing robotic bariatric surgery
Key facts
- Sponsor
- Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 13 Nov 2025 → ongoing
- Decision date (initial)
- 2025-07-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Safety
To determine whether opioid-free general anesthesia, compared to opioid-based general anesthesia, reduces the frequency and intensity of postoperative nausea and vomiting in patients undergoing robotic bariatric surgery
Secondary objectives 2
- To compare the level of postoperative pain using opioid-free general anesthesia versus opioid-based general anesthesia in patients undergoing robotic bariatric surgery
- To compare the average postoperative opioid dose required to maintain pain control below 4 points on the Visual Analog Scale (VAS) in each of the two groups
Conditions and MedDRA coding
Obesity
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10029883 | Obesity | 100000004861 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Electively scheduled patients for bariatric surgery
- Both sexes
- Age between 18 and 75 years
- ASA classification I-III
- Signed informed consent
Exclusion criteria 8
- Patients with decompensated hepatic, cardiac, or renal insufficiency
- Patients with second-degree or higher heart block
- Patients with a history of chronic pain
- Patients with substance dependence
- Allergy to any of the medications used
- Pregnant or lactating women
- Use of opioid medications within the last 24 hours
- Refusal to participate or failure to sign the informed consent
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Visual Analog Scale for Nausea (VAS-N)
Secondary endpoints 2
- Visual Analog Scale for Pain (VAS-P)
- Opioid demand during the 24 hours following surgery
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
KETOLAR 50 mg/ml solución inyectable.
PRD358161 · Product
- Active substance
- Ketamine Hydrochloride
- Substance synonyms
- KET01, KETAMINI HYDROCHLORIDUM, 2-(2-CHLOROPHENYL)-2-METHYLAMINO-CYCLOHEXAN-1-ONE HYDROCHLORIDE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 1 mg/kg/h milligram(s)/kilogram/hour
- Max total dose
- 1 mg/kg/h milligram(s)/kilogram/hour
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AX03 — KETAMINE
- Marketing authorisation
- 47.034
- MA holder
- PFIZER S.L.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dexdor 100 micrograms/ml concentrate for solution for infusion
PRD3495423 · Product
- Active substance
- Dexmedetomidine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 1 µg/Kg microgram(s)/kilogram
- Max total dose
- 1 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N05CM18 — -
- Marketing authorisation
- EU/1/11/718/006
- MA holder
- ORION CORPORATION
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sulfato de Magnesio Altan 150 mg/ml solución inyectable y para perfusión EFG
PRD990728 · Product
- Active substance
- Magnesium Sulfate Heptahydrate
- Substance synonyms
- MAGNESIUM SULPHATE HEPTAHYDRATE
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 3 g gram(s)
- Max total dose
- 3 g gram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA05 — MAGNESIUM SULFATE
- Marketing authorisation
- 78350
- MA holder
- ALTAN PHARMACEUTICALS S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB88133 · Substance
- Active substance
- Lidocaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 3 mg/kg/h milligram(s)/kilogram/hour
- Max total dose
- 3 mg/kg/h milligram(s)/kilogram/hour
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre
- Sponsor organisation
- Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre
- Address
- Avinguda De L'Alcalde Rovira Roure 80
- City
- Lleida
- Postcode
- 25196
- Country
- Spain
Scientific contact point
- Organisation
- Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre
- Contact name
- Diego Arango Del Corro
Public contact point
- Organisation
- Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre
- Contact name
- Diego Arango Del Corro
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Temporarily halted | 64 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2025-11-13 | 2025-11-13 | 2026-03-18 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-129466
- Halt date
- 2026-03-18
- Member states concerned
- Spain
- Publication date
- 2026-04-16
- Reason
- Study management related, Investigator/Site related
- Explanation
- The temporary halt is due to study management and site-related issues specifically regarding a systematic failure in the randomization and treatment administration workflow. A serious breach was identified where two subjects were cross-overed due to inadequate onboarding of external medical staff. The sponsor has decided to halt recruitment to implement a Corrective and Preventive Action (CAPA) plan focused on re-training and strengthening the communication protocols between the research team and the surgical department to ensure future data integrity.
- Follow-up measures
- The sponsor has implemented a comprehensive Corrective and Preventive Action (CAPA) plan (Ref: CAPA_ANG_2026_001).
For the affected subjects (ANG_15 and ANG_18). Clinical monitoring for these subjects has been completed as per protocol (24 hours post-surgery). No adverse events or safety concerns were identified during their participation. Both subjects have been informed of the treatment crossover. Their safety data will be included in the safety analysis, but their primary endpoint efficacy data will be excluded from the Per-Protocol (PP) analysis due to the randomization error.
A session for the entire anesthesia and surgical staff was conducted and finalized on April 14, 2026, covering randomization workflows and treatment arm identification.
Recruitment remains halted until the final retrospective pharmacy reconciliation (CA-03) is completed and verified by the sponsor to ensure the reliability of the drug accountability logs for all previously enrolled subjects." - Benefit-risk balance changed
- No
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-521047-20-00 | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | DEXDOR | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | KETAMINA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | LIDOCAINA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SULFATO DE MAGNESIO | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-521047-20-00_ENG | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-521047-20-00_ESP | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-14 | Spain | Acceptable 2025-07-18
|
2025-07-22 |