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Comparative study of analgesia by the use of intravenous and subarachnoid clonidine in patients submitted to Videoolaparoscopic Cholecystectomy

Comparative study of the use of intravenous and subarachnoid clonidine in patients submitted to Videoolaparoscopic Cholecystectomy - VLP - Videolaparoscopy: CVLP - Videolaparoscopic Cholecystectomy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-33vyhm
Enrollment
Unknown
Registered
2018-06-29
Start date
2017-08-23
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Cholelithiasis.

Interventions

After the authorization of the Research Ethics Committee (CEP), the selection of patients with a diagnosis of cholelithiasis (following the inclusion and exclusion criteria) was started at the General
Drug
E03.091

Sponsors

Fundação Universidade do Amazonas
Lead Sponsor
Hospital Universitário Getúlio Vargas
Collaborator

Eligibility

Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Voluntary patients; of both sexes; with full autonomy; ages ranging from 18 to 50 years; weight between 50 and 100 kg; with diagnosis of cholelithiasis; classification I or II of the physical state according to the scale of the American Society of Anesthesiologists.

Exclusion criteria

Exclusion criteria: Patients who refuse to sign the informed consent form (EHIC); withdrawals; pregnant or nursing mothers; indigenous peoples; minor or legally incapable; patients with special needs; patients on uninterrupted use of analgesics; with a history of hypersensitivity to any of the medications used in the procedure; patients diagnosed with depression; patients with liver disease, nephropathy or with blood coagulation disorders; conversion of videolaparoscopic surgery in conventional open surgery.

Design outcomes

Primary

MeasureTime frame
The primary variables presented in the study are pain estimation, blood pressure and heart rate values defined by a numerical scale ranging from 0 to 10, as well as blood pressure and heart rate variables, which are also defined by numerical values . The project intends to perform the analysis of the selected groups and to correlate with the need for the use of analgesics in the postoperative period, through the parameters obtained in the pain control protocols. ;According to the comparison between the anesthetic technique used in each group and the need for supplementary medications, it is proposed that the association of the drug clonidine reduces the need for analgesics in the immediate postoperative period through a certain route of administration.

Secondary

MeasureTime frame
Secondary variables correspond to patient's pain in the immediate postoperative period, according to age, gender, presence of adverse effects, and the need for analgesic drugs beyond routine postoperative prescription, which will be defined by qualitative values and quantitative.

Countries

Brazil

Contacts

Public ContactChristiane da Silva

Hospital Universitário Getúlio Vargas

christianerdasilva@gmail.com55 092 98802-0128

Outcome results

None listed

Source: REBEC (via WHO ICTRP)