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Clinical Trials/EUCTR2021-003245-38-ES
EUCTR2021-003245-38-ES
Active, not recruiting
Phase 1

Randomized clinical trial to compare the efficacy of opioid-free versus traditional balanced anesthesia in laparoscopic colorectal surgery - OFA_GAL_21

nai Ortega Mera0 sites164 target enrollmentNovember 10, 2021
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Conditionslaparoscopic colorectal surgeryTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
DrugsPropofol HospiraSupraneBridionRocuronio B. BraunParacetamol AccordEnantyumMorfina B. BraunLevobupivacaina Normon

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
laparoscopic colorectal surgery
Sponsor
nai Ortega Mera
Enrollment
164
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 10, 2021
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
nai Ortega Mera

Eligibility Criteria

Inclusion Criteria

  • •? Patients aged 18 years or older.
  • •? Patients with scheduled laparoscopic colorectal surgery.
  • •? Patients with physical status classification (ASA) I\-III.
  • •? Patients who have signed the informed consent for the clinical trial
  • •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 164
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •? Pregnant or lactating patients.
  • •? Patients with an allergy to any of the drugs or excipients used in the study.
  • •? Emergency laparoscopic colorectal surgery.
  • •? Patients with physical status classification (ASA) IV.
  • •? Patients with AV block, intraventricular or sinus block.
  • •? Adam\-Stokes syndrome.
  • •? Patient on chronic beta\-blockers treatment with HR \<50 bpm.
  • •? Patient with known ejection fraction \<40%.
  • •? Epilepsy.
  • •? Chronic opioid user.

Outcomes

Primary Outcomes

Not specified

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