Ignite Creation Date:
2024-05-06 @ 5:40 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05382624
Status:
COMPLETED
Last Update Posted:
2022-05-19
First Post:
2022-05-07
Brief Title:
The Relationship Between Abdominal Circumference Hip Ratio and Ephedrine Requirement
Sponsor:
Ataturk University
Organization:
Ataturk University
Study Overview
Official Title:
The Relationship Between Abdominal Circumference Hip Ratio and Ephedrine Requirement in Spinal Anesthesia for Elective Cesarean A Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2022-05
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 prospective observational study aimed to investigate whether there is a relationship between weight height BMI abdominal circumference AC hip circumference HC and AC-to-hip ratio with the incidence of hypotension in patients undergoing cesarean section under spinal anesthesia
Detailed Description:
This prospective observational study was conducted over eight months from March 2021 to October 2021 at the Anesthesiology and Reanimation Department of Erzurum Regional Training and Research Hospital Erzurum Turkey a tertiary care hospital Before commencing the study the Institute ethics committee approval was taken from the Ethical Committee of Health Sciences University Erzurum Regional Training and Research Hospital Erzurum Turkey This study was carried out in accordance with the Declaration of Helsinki and written informed consent was obtained from all participants
The study population comprised 60 women who agreed to participate with uncomplicated term pregnancies BMI 30 kgm2 aged between 18-45 years ASA I and II undergoing elective cesarean section under spinal anesthesia Participants with a complicated pregnancy such as diabetes hypertension fetal anomaly a history of allergy to study drugs psychiatric diseases coagulation abnormalities and multiple pregnancies were excluded from the study Also patients who required conversion to general anesthesia were excluded
A day before surgery patients were informed about the study and written informed consent was obtained from participants On the day of the operation all participants were preloaded with 500 milliliters of Ringers lactate through a 16-18 gauge intravenous cannula In the operating room standard monitorization including non-invasive blood pressure electrocardiography and pulse oximetry was provided Before the spinal anesthesia patients age weight height abdominal and hip circumferences ASA physical status baseline values of noninvasive blood pressure and heart rate HR were recorded
Abdominal circumference was measured at the umbilical level in the standing position at the end of a normal expiration Hip circumference was measured at the widest circumference over the buttocks All the measurements were carried out by the trained anesthesia technician using standard non-stretch tape with the parturients wearing light clothes To minimize errors three consecutive measurements were obtained results were averaged and the AC-to-hip ratio was calculated by dividing the values of the abdominal cm and hip circumference cm
Spinal anesthesia in the sitting position was performed on all patients Following skin sterilization a 27-gauge Quincke-tip spinal needle was advanced through the midline L3-4 intervertebral space After free cerebrospinal fluid flow was observed 24 ml 05 hyperbaric bupivacaine 12 mg was injected over 30 seconds Then the spinal needle was removed and patients were placed in the supine position for the operation and the operating table was tilted 20 to the left A pinprick test was used to evaluate the sensory block level and surgery was initiated when the sensory block reached the T6 dermatome Spinal anesthesia was considered to have failed when the sensory block was not consistent within the first 20 minutes following the spinal injection In this instance general anesthesia was performed and these patients were excluded from the study A Modified Bromage scale was used to evaluate the motor block level After delivery of the baby 20 IU oxytocin in 1000 ml Ringers lactate solution was given intravenously over 5 hours Hypotension a 20 decrease in systolic blood pressure compared to preoperative values was treated by uterine displacement and rapid infusion of fluid Intravenous ephedrine 5 mg was given in case of persistent hypotension Intravenous atropine 1 mg was injected to treat bradycardia the HR 45 beatsminute In our clinic ephedrine is routinely used as the first choice in the treatment of hypotension Intravenous ondansetron 4 mg was used to treat persistent nausea and vomiting Following spinal injection systolic diastolic and mean arterial pressure and HR values were recorded every 2 minutes for 20 minutes and then every 5 minutes until the end of the operation The operation time the time from the beginning of the surgical incision until the end of surgery anesthetic complications such as nausea or vomiting the number of patients requiring ephedrine and atropine the total amount of intravenous fluid used and the total amount of ephedrine used during surgery were recorded Neonatal Apgar scores at 1 and 5 minutes after delivery and the weight and height of the neonates were recorded After surgery patients were transferred to the recovery room Pain severity was assessed via the Visual analog scale VAS 0 cmno pain 10 cmworst pain In the case of VAS 3 1 gr paracetamol was given to patients intravenously Anesthesia-related side effects eg nausea vomiting and headache sensory block time from the spinal injection to the recovery of T10 dermatome and the time requiring supplemental analgesics was recorded by an independent observer blinded to the group assignment at 30 min and 1st and 2nd hours post-operatively When the motor block had regressed to the T10 level patients were sent to the clinics
Statistical Analysis The sample size calculation was performed based on the data gained from the studys preliminary results using Russ Lenths power and sample size calculation application 13 Fifty-eight patients were needed to detect an anticipated effect size of 037 with a power of 85 and an alpha of 5
The statistical analysis of all data was performed with SPSS 20 software SPSS Inc Chicago IL USA and P005 was considered statistically significant Data were expressed as mean values standard deviation SD median min-max or number and percentage values Kolmogorov-Smirnov test was used to detect the distribution of data
Pearson correlation analysis was performed to assess the association between anthropometric measures ie BMI AC-to-hip ratio with the incidence of hypotension and the total amount of ephedrine used Correlation analysis was performed to find the correlations between the total amount of ephedrine used and the AC HC and AC-to-hip ratio The correlation between the total amount of ephedrine used and the weight of the fetus was also investigated The regression equations were obtained by using the linear regression method and the coefficients r2 were compared
The study population comprised 60 women who agreed to participate with uncomplicated term pregnancies BMI 30 kgm2 aged between 18-45 years ASA I and II undergoing elective cesarean section under spinal anesthesia Participants with a complicated pregnancy such as diabetes hypertension fetal anomaly a history of allergy to study drugs psychiatric diseases coagulation abnormalities and multiple pregnancies were excluded from the study Also patients who required conversion to general anesthesia were excluded
A day before surgery patients were informed about the study and written informed consent was obtained from participants On the day of the operation all participants were preloaded with 500 milliliters of Ringers lactate through a 16-18 gauge intravenous cannula In the operating room standard monitorization including non-invasive blood pressure electrocardiography and pulse oximetry was provided Before the spinal anesthesia patients age weight height abdominal and hip circumferences ASA physical status baseline values of noninvasive blood pressure and heart rate HR were recorded
Abdominal circumference was measured at the umbilical level in the standing position at the end of a normal expiration Hip circumference was measured at the widest circumference over the buttocks All the measurements were carried out by the trained anesthesia technician using standard non-stretch tape with the parturients wearing light clothes To minimize errors three consecutive measurements were obtained results were averaged and the AC-to-hip ratio was calculated by dividing the values of the abdominal cm and hip circumference cm
Spinal anesthesia in the sitting position was performed on all patients Following skin sterilization a 27-gauge Quincke-tip spinal needle was advanced through the midline L3-4 intervertebral space After free cerebrospinal fluid flow was observed 24 ml 05 hyperbaric bupivacaine 12 mg was injected over 30 seconds Then the spinal needle was removed and patients were placed in the supine position for the operation and the operating table was tilted 20 to the left A pinprick test was used to evaluate the sensory block level and surgery was initiated when the sensory block reached the T6 dermatome Spinal anesthesia was considered to have failed when the sensory block was not consistent within the first 20 minutes following the spinal injection In this instance general anesthesia was performed and these patients were excluded from the study A Modified Bromage scale was used to evaluate the motor block level After delivery of the baby 20 IU oxytocin in 1000 ml Ringers lactate solution was given intravenously over 5 hours Hypotension a 20 decrease in systolic blood pressure compared to preoperative values was treated by uterine displacement and rapid infusion of fluid Intravenous ephedrine 5 mg was given in case of persistent hypotension Intravenous atropine 1 mg was injected to treat bradycardia the HR 45 beatsminute In our clinic ephedrine is routinely used as the first choice in the treatment of hypotension Intravenous ondansetron 4 mg was used to treat persistent nausea and vomiting Following spinal injection systolic diastolic and mean arterial pressure and HR values were recorded every 2 minutes for 20 minutes and then every 5 minutes until the end of the operation The operation time the time from the beginning of the surgical incision until the end of surgery anesthetic complications such as nausea or vomiting the number of patients requiring ephedrine and atropine the total amount of intravenous fluid used and the total amount of ephedrine used during surgery were recorded Neonatal Apgar scores at 1 and 5 minutes after delivery and the weight and height of the neonates were recorded After surgery patients were transferred to the recovery room Pain severity was assessed via the Visual analog scale VAS 0 cmno pain 10 cmworst pain In the case of VAS 3 1 gr paracetamol was given to patients intravenously Anesthesia-related side effects eg nausea vomiting and headache sensory block time from the spinal injection to the recovery of T10 dermatome and the time requiring supplemental analgesics was recorded by an independent observer blinded to the group assignment at 30 min and 1st and 2nd hours post-operatively When the motor block had regressed to the T10 level patients were sent to the clinics
Statistical Analysis The sample size calculation was performed based on the data gained from the studys preliminary results using Russ Lenths power and sample size calculation application 13 Fifty-eight patients were needed to detect an anticipated effect size of 037 with a power of 85 and an alpha of 5
The statistical analysis of all data was performed with SPSS 20 software SPSS Inc Chicago IL USA and P005 was considered statistically significant Data were expressed as mean values standard deviation SD median min-max or number and percentage values Kolmogorov-Smirnov test was used to detect the distribution of data
Pearson correlation analysis was performed to assess the association between anthropometric measures ie BMI AC-to-hip ratio with the incidence of hypotension and the total amount of ephedrine used Correlation analysis was performed to find the correlations between the total amount of ephedrine used and the AC HC and AC-to-hip ratio The correlation between the total amount of ephedrine used and the weight of the fetus was also investigated The regression equations were obtained by using the linear regression method and the coefficients r2 were compared
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