Effect of Different Left Lateral Table Tilt for Elective Cesarean Delivery Under Spinal Anesthesia

Spinal Anesthesia Clinical Trial

Official title:

Effect of Different Left Lateral Table Tilt on Neonatal Acid-base Status and Maternal Hemodynamics for Elective Cesarean Delivery Under Spinal Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04083768
• Other study ID #: XYFY2019-KL126-02
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: February 10, 2020

Study information

• Verified date: June 2021
• Source: Xuzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The recommended position of the mother under caesarean section after spinal anesthesia is 15 degrees left. However, recent research has challenged the basic principles and practicality of the left-turn 15 degree position. Higuchi et al used nuclear magnetic imaging to directly prove that in the supine position, the position of the full-left 30 degrees of the full-term pregnancy of the full-term pregnancy relieved the inferior vena cava compression and the left-angle of 15 degrees did not. Therefore, there are more and more controversies about the choice of cesarean section position. This experiment aims to explore effects of different positions (15 degrees left, 30 degrees left and supine) for elective cesarean section on lumbar anesthesia for fetal acid-base balance and maternal Hemodynamic.

Description:

When the pregnant woman in the third trimester is in the supine position, the enlarged uterus may oppress the inferior vena cava, thereby reducing the amount of blood and heart output of the pregnant woman. This affects the mother mainly, such as dizziness, nausea and vomiting, chills, and severe irritability，difficulty breathing or even cardiac arrest, the impact on the fetus is mainly the reduction of blood flow in the placenta, affecting the blood exchange of the uterus placenta, causing neonatal respiratory distress, acidosis and even death. The recommended position of the mother under caesarean section after spinal anesthesia is 15 degrees left. However, recent research has challenged the basic principles and practicality of the left-turn 15 degree position. Higuchi et al used nuclear magnetic imaging to directly prove that in the supine position, the position of the full-left 30 degrees of the full-term pregnancy of the full-term pregnancy relieved the inferior vena cava compression and the left-angle of 15 degrees did not. Therefore, there are more and more controversies about the choice of cesarean section position. This experiment aims to explore effects of different positions (15 degrees left, 30 degrees left and supine) for elective cesarean section on lumbar anesthesia for fetal acid-base balance and maternal Hemodynamic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 10, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Singleton pregnancy at term via elective cesarean section
• Height from 150 cm to 180 cm
• American Society of Anesthesiologists (ASA) grade from I to II grade
• BMI(Body Mass Index,mearsured weight divided by height squared)less than 35 kg/m2.

Exclusion Criteria:

• Transverse lie
• Fetal macrosomia
• Uterine abnormalities (e.g., large fibroids, bicornuate uterus)
• Polyhydramnios
• Ruptured membranes
• Oligohydramnios
• Intrauterine growth restriction
• Gestational or nongestational hypertension, diabetes, eclampsia
• Hypertensive disorder or any condition associated with autonomic neuropathy (e.g., diabetes mellitus for more than 10 yr), with renal failure
• Have contraindications for spinal anesthesia(Such as low back infection, spinal deformity, etc.)
• Participants refused to sign informed consent.

Related Conditions & MeSH terms

• Elective Cesarean Section
• Spinal Anesthesia

Intervention

Device:
• 15° and 30° wedge sponges
After the spinal anesthesia is completed, the wedge sponge is placed between the patient's pelvis and ribs and the wedge is removed before the skin is cut.

Locations

Country	Name	City	State
China	Liu Tian yu	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xuzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

Abengochea A, Morales-Roselló J, Del Río-Vellosillo M, Argente P, Barberá M. Effect of lateral tilt angle on the volume of the abdominal aorta and inferior vena cava in pregnant and nonpregnant women determined by magnetic resonance imaging. Anesthesiology. 2015 Sep;123(3):733-4. doi: 10.1097/ALN.0000000000000791. — View Citation

Crawford JS, Burton M, Davies P. Time and lateral tilt at Caesarean section. Br J Anaesth. 1972 May;44(5):477-84. — View Citation

Fujita N, Higuchi H, Sakuma S, Takagi S, Latif MAHM, Ozaki M. Effect of Right-Lateral Versus Left-Lateral Tilt Position on Compression of the Inferior Vena Cava in Pregnant Women Determined by Magnetic Resonance Imaging. Anesth Analg. 2019 Jun;128(6):1217-1222. doi: 10.1213/ANE.0000000000004166. — View Citation

Shayegan B, Khorasani A, Knezevic NN. Left Lateral Table Tilt for Elective Cesarean Delivery under Spinal Anesthesia Should Not Be Abandoned. Anesthesiology. 2018 Apr;128(4):860-861. doi: 10.1097/ALN.0000000000002095. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Umbilical artery blood pH	Use a blood gas analyzer to measure	Immediately after delivery
Secondary	Other UA and UV blood gas analysis values(pH, base excess, lactate , Umbilical artery blood PaCO2	Use a blood gas analyzer to measure, PaCO2 in mmHg.	Immediately after delivery
Secondary	Fetal Apgar score (1 minute after birth) And 5 minutes	Measured by Apgar score.The Apgar scoring system is divided into five categories(muscle tone,heart rate,grimace and respiration) Appearance. Each category receives a score of 0 to 2 points. At most, a child will receive an overall score of 10(The higher the score, the better the child's condition).	One minute and five minutes after the baby is delivered
Secondary	The incidence of nausea in pregnant women	Anesthesiologist observes combined patient dictation.	Intraoperative
Secondary	The incidence of vomiting in pregnant women	Anesthesiologist observes combined patient dictation	Intraoperative
Secondary	The incidence of hypotension in pregnant women	The increase of SBP <20% baseline SBP or SBP < 90/60mmHg	Intraoperative
Secondary	The incidence of hypertension in pregnant women	The increase of SBP >20% baseline SBP	Intraoperative
Secondary	The incidence of bradycardia in pregnant women	Heart rate less than 60 times per minute	Intraoperative
Secondary	One min (T1), 3 min (T2), 5 min (T3), 7 min (T4), 9 min (T5), 11 min (T6), 13 min (T7) and 15 min (T8) blood pressure after subarachnoid injection (completion of the subarachnoid injection was defined as 0 time point)	Measured by a sphygmomanometer.Systolic and diastolic blood pressure will be measured every minute during the study.	Intraoperative
Secondary	One min (T1), 3 min (T2), 5 min (T3), 7 min (T4), 9 min (T5), 11 min (T6), 13 min (T7) and 15 min (T8) heart rate after subarachnoid injection (completion of the subarachnoid injection was defined as 0 time point)	Obtained by ECG measurement	Intraoperative
Secondary	Dosage of phenylephrine during surgery	Used by an anesthesiologist based on the patient's blood pressure and heart rate.If the patient's blood pressure is less than 80% of the baseline level or less than 90/60 mmHg and the heart rate is greater than 60 times per minute, the patient is given 4 ug of phenylephrine.	Intraoperative
Secondary	Dosage of ephedrine during surgery	Used by an anesthesiologist based on the patient's blood pressure and heart rate.If the patient's blood pressure is less than 80% of the baseline level or less than 90/60 mmHg and the heart rate is smaller than 60 times per minute, the patient is given 6 mg of ephedrine.	Intraoperative
Secondary	Dosage of atropine during surgery	Used by an anesthesiologist based on the patient's blood pressure and heart rate.If the patient's heart rate is smaller than 60 times per minute, and blood pressure is more than 80% of the baseline level and more than 90/60 mmHg, the patient is given 0.5 mg of atropine.	Intraoperative