Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410820
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-04-04
Brief Title:
Ultrasound Guided Versus Land-mark Method for Spinal Anesthesia in Super Obesity Parturients
Sponsor:
Karaman Training and Research Hospital
Organization:
Karaman Training and Research Hospital
Study Overview
Official Title:
Comparison of Ultrasound and Anatomical Landmark Method in Spinal Anesthesia for Elective Cesarean Section in Super Obese Parturients With BMI 50 kgm2 A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will investigate whether an ultrasound-assisted technique is better than a classical land-mark technique to facilitate spinal anesthesia in the sitting position in super obese pregnant women with BMI 50 who will undergo elective cesarean section
The primary objective of this study is the rate of successful dural puncture at the first attempt It was assumed that ultrasound could facilitate neuraxial blockade in super obese BMI 50 kgm2 pregnant women according to the Who classification whose topographic anatomy is difficult
The primary objective of this study is the rate of successful dural puncture at the first attempt It was assumed that ultrasound could facilitate neuraxial blockade in super obese BMI 50 kgm2 pregnant women according to the Who classification whose topographic anatomy is difficult
Detailed Description:
Spinal anesthesia is the most commonly used anesthesia method for elective cesarean deliveries Anesthesiologists may struggle to determine the poorly palpable surface landmarks in super obese BMI 50 kgm2 pregnant women
The manual palpation technique preferred in neuraxial anesthesia may be very difficult in super obese pregnant women due to difficulty identifying bone landmarks Neuraxial ultrasound examination before spinal anesthesia may help spinal anesthesia performance and decrease the number of attempts in obese parturients
This study will be a single-center prospective randomized double-blinded trial in a university hospital Patients scheduled for elective cesarean will be screened for enrollment in the study The anesthetist administering spinal anesthesia and evaluating the data were blind to the distribution of patient groups Ultrasonographic examinations were performed by a single investigator trained in this technique who performed more than 60 ultrasound-guided neuraxial blocks
The manual palpation technique preferred in neuraxial anesthesia may be very difficult in super obese pregnant women due to difficulty identifying bone landmarks Neuraxial ultrasound examination before spinal anesthesia may help spinal anesthesia performance and decrease the number of attempts in obese parturients
This study will be a single-center prospective randomized double-blinded trial in a university hospital Patients scheduled for elective cesarean will be screened for enrollment in the study The anesthetist administering spinal anesthesia and evaluating the data were blind to the distribution of patient groups Ultrasonographic examinations were performed by a single investigator trained in this technique who performed more than 60 ultrasound-guided neuraxial blocks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None