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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05091294
Other study ID # 2020-52
Secondary ID Ahmet Besir
Status Completed
Phase N/A
First received
Last updated
Start date February 11, 2020
Est. completion date July 30, 2021

Study information

Verified date January 2022
Source Karadeniz Technical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized double-blind study aimed to compare the effects of two different subaracnoid lokal anesthetic injection rate in cesarean section. Totally 67 patients were included. The groups were compared in terms of maximum sensory and motor block level, time to reach T6 level, hemodynamic changes and nausea- vomiting saved.


Description:

A total of 67 patients 18-40 years undergoing cesarean, who were graded as American Society of Anesthesiologists physical status were randomly allocated into two groups, 120-sn injection time (n=34, Group F), 15-sn injection time (n=33, Group S). When the level of the sensory block achieve the T6 level the surgery was let to begin. The groups were compared in terms of hemodynamic values, use of efedrin, the time to achieve sensory block to the T6 level, maximum sensory block level and motor block level.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date July 30, 2021
Est. primary completion date January 25, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Anesthesiologists risk score (ASA) I-II risk status - Singleton pregnancy aged - Between 18-40 years Exclusion Criteria: - Pregnant women with contraindications for spinal anesthesia; - Placental anomaly; - Hypertension - Cardiac disease - Vascular disease - Hepatic disease - Renal disease - Hemodynamic instability - Spinal deformity; - Severe mental retardation - Weight < 50 kg or >110 kg; height < 140 cm or > 180 cm - Metabolic and Acid-base balance disorders - Emergency patients

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Local anesthetic injection rate in spinal anesthesia
Administering intrathecal local anesthetics for all patients according to height and weight.

Locations

Country Name City State
Turkey Karadeniz Technical University Trabzon

Sponsors (1)

Lead Sponsor Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary sensory block The time to reach the sufficient sensory block and maximum level of sensory block was significantly shorter in Group S 2 minutes interval
Primary Hypotension The time to onset of hypotension was significantly shorter in Group F 2 minutes interval
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