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Comparison of recovery after addition of a medication to spinal anesthesia in patients undergoing uterine removal

Quality of recovery after hysterectomy surgery with the use of clonidine in spinal anesthesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-3tt2zhz
Enrollment
Unknown
Registered
2024-10-09
Start date
2025-01-01
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

Hysterectomy

Interventions

This is a randomized controlled clinical trial, double-blind, with 40 participants in each group. The inclusion criteria are: being female, aged between 18 and 65 years
undergoing an abdominal hysterectomy, with or without oophorectomy
having an ASA physical status classification of 1 or 2. The exclusion criteria include: contraindication to any medication used in the study
refusal to participate in the study
refusal of neuroaxial anesthesia
illiteracy. Exclusion criteria cover: perioperative bleeding greater than expected
allergic reaction to any components of the protocol
need for technical changes in surgical or anesthetic procedures during the operation. After ethical approval and registration in the Brazilian Registry of Clinical Trials, participants will be randoml
the control group will receive 15 mg of bupivacaine with 5% glucose, 80 micrograms of morphine, and 0.6 milliliters of 0.9% saline, substituting the clonidine. The anesthetic solution will be prepared

Sponsors

Faculdade de Ciências Médicas e da Saúde da Pontifícia Universidade Católica de São Paulo
Lead Sponsor
Faculdade de Ciências Médicas e da Saúde da Pontifícia Universidade Católica de São Paulo
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: age between 18 and 65 years; woman; underwent abdominal hysterectomy; american society of anesthesiology physical status 1 and 2

Exclusion criteria

Exclusion criteria: illiterate; contraindication to any medication used in the research; refusal to spinal anesthesia

Design outcomes

Primary

MeasureTime frame
The quality of recovery will be assessed using the "Quality of Recovery 15" questionnaire in patients undergoing abdominal hysterectomy under spinal anesthesia, with and without clonidine, between 24 and 36 hours postoperatively

Secondary

MeasureTime frame
During the intraoperative period, the doses of intraoperative ephedrine and atropine will be assessed, as well as the incidence of heart rates below 60 and 50 beats per minute. In the post-anesthetic recovery room, the dose of morphine administered, the incidence of nausea and vomiting, and the length of stay will be evaluated

Countries

Brazil

Contacts

Public ContactAntonio Moron Morad Neto

Faculdade de Ciências Médicas e da Saúde da Pontifícia Universidade Católica de São Paulo

juarezmoron@gmail.com+55(15)3212-9900

Outcome results

None listed

Source: REBEC (via WHO ICTRP)