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Evaluation Forms of Anestesia for Human Reproduction

Comparative Study Between Two Anesthetic Techniques For Follicular Puncture Guided By Transvaginal Ultrasound

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8kqqxh
Enrollment
Unknown
Registered
2014-02-10
Start date
2014-01-10
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

Infertility, female infertility.

Interventions

GROUP 1: 30 patients
deep sedation by Fentanyl(1 mcg / kg) intravenously, followed by the administration of Propofol at a dose of bolus – 50 milligrams (50mg) intravenously, in titrated dose, registering the repeated valu
minimal sedation by Midazolam(0.075 mg/kg), associated to Remifentanil in continually at an initial dose of 0.25 micograms/kilo/minute (0.25 mcg/kg/min) and infiltration with 2 milliliters (ml) of lid
Drug
Procedure/surgery

Sponsors

Faculdade de Medicina do ABC
Lead Sponsor
Centro de Reprodução Humana e Genética da Faculdade de Medicina do ABC
Collaborator

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: Women with the presence of at least one follicle bigger than 14 millimeters, to be punctured; Aged between 20 to 40 years old; with a diagnosis of infertility patients who attempted to spontaneous pregnancy for at least 12 months with regular sexual activity and without the use of contraceptives, however, failed to achieve pregnancy; Body Mass Index (BMI) between 20 and 30; Surgical risk by American Society of Anesthesiologists (ASA) 1 or 2.

Exclusion criteria

Exclusion criteria: Incomplete medical records; Carriers of chromosomal diseases; donor oocytes; Pathologies associeted with surgical risk ASA III, IV, V and VI; Presence of known allergy to anesthethic drugs used in this study

Design outcomes

Primary

MeasureTime frame
Finding difference between the number of punctured follicles in both groups, when subjected to different anesthetic techniques (sedation with propofol and fentanyl compared to sedation with midazolam and remifentanil, paracervical block) defines the value of standard deviation of 5.4 punctured follicles; difference of 4.3 punctured follicles to be detected; significance level of 5%, a power of 80% and a loss of approximately 10% (ARMITAGE & BERRY, 1987; Hammadhen et al, 1999).

Secondary

MeasureTime frame
Evaluate the vital signs parameters: heart rate, oxygen saturation, arterial pressure non-invasive. Compare importante questions in ambulatory anestesia: evaluate the Aldrete-Kroulik criteria in two and five minutes, and the required time to reach values of 10, this is a score that evaluates the degree of awakening of the patient so she can be released from the anesthetic recovery.

Countries

Brazil

Contacts

Public ContactGilvandro de Oliveira Júnior

Faculdade de Medicina do ABC

gilvandrolins@hotmail.com+55(11)49935464

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 12, 2026