Colloid Preload Versus Colloid Coload During Cesarean Deliveries

Hypotension Clinical Trial

Official title:

Colloid Preload Versus Colloid Coload in Preventing Spinal Anesthesia-Induced Hypotension During Cesarean Section Deliveries: A Prospective, Randomized, Double-Blind Comparative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02393196
• Other study ID #: SifaU
• Status: Recruiting
• Phase: Phase 4
• First received: March 1, 2015
• Last updated: November 16, 2015
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: November 2015
• Source: Sifa University
• Contact: Aysun Afife Kar, MD
• Phone: +905326521313
• Email: aaysunkar[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Drug and Medical Device Institution
• Study type: Interventional

Clinical Trial Summary

The investigators aimed to compare the methods colloid preloading and colloid coloading in terms of the incidence of maternal hypotension and impacts on neonatal outcomes. The second aim while planning the present study is to identify the method of the lowest adverse event for mother and infant and the simplest approach for the clinician.

Description:

Spinal anesthesia (SA) is currently the most preferred method of anesthesia in elective cesarean deliveries. However, SA causes maternal hypotension by decreasing systemic vascular resistance over sympathetic blockade. Maternal hypotension can lead to serious adverse events both in mother and in fetus: fetal hypoxia and acidosis occur due to decreased uterine blood flow, whereas the mother may experience vertigo, nausea, vomiting, alteration in consciousness, cardiovascular collapse and arrest. Today, various strategies have been suggested for the prevention of maternal hypotension. Of these strategies, the most critical ones are fluid load before spinal anesthesia (preloading) or rapid fluid load just after spinal anesthesia (coloading) and the use of vasopressor agent. The fluids used for this purpose include crystalloids and colloids. Comparative studies performed with colloid preloading, colloid coloading and crystalloid coloading indicated that the incidence of hypotension decreased similarly with no significant difference determined between the methods of fluid loading. Researchers defended necessity of using vasopressor agent together with fluid loading methods. In daily routine; however, the investigators observe that the incidence of hypotension is lower in the patients that undergo colloid preloading as compared to the patients that undergo colloid coloading or crystalloid coloading. The investigators therefore aimed to compare the methods colloid preloading and colloid coloading in terms of the incidence of maternal hypotension and impacts on neonatal outcomes. In the present study, the investigators aimed to use 6% HES 130/0.4 (Voluven ®), which is the newer generation colloid solution. The other aim while planning the present study is to identify the method of the lowest adverse event for mother and infant and the simplest approach for the clinician.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older

• Singleton pregnancy

• Gestational age = 37 weeks

• Height = 150 cm and = 180 cm

• Weight > 50 kg and < 100 kg

Exclusion Criteria:

• Gestational age > 37 weeks

• Multiple pregnancies

• Fetal distress

• Preeclampsia

• Cardiovascular disease and diabetes

• Hematological problems

• Local infection at intervention site

• Abnormal coagulation tests

• Anticoagulant use

• Starch allergy

• Height < 150 cm and > 180 cm

• Weight < 50 kg and > 100 kg

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anesthesia; Adverse Effect, Spinal and Epidural
• Hypotension

Intervention

Drug:
• hydroxyethyl starch (% 6 HES 130/0.4) (Voluven®)
Before spinal anesthesia
• hydroxyethyl starch (%6 HES 130/0.4) (Voluven®)
Just after spinal anesthesia

Locations

Country	Name	City	State
Turkey	Sifa Üniversitesi, Basmane Hastanesi	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Sifa University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Preoperative fasting period.	preoperative fasting period will be recorded.	Time before spinal anesthesia. Participants will be followed for the duration of hospital stay, an expected average of two days.	No
Other	Preoperative hemoglobin concentration (g/dL).	Before spinal anesthesia. Participants will be followed for the duration of hospital stay, an expected average of two days.	Time before spinal anesthesia. Participants will be followed for the duration of hospital stay, an expected average of two days.	No
Other	Durations of anesthesia and surgery.	Time period from induction of spinal anesthesia to skin incision (min), time period from induction of spinal anesthesia to delivery (min), time period from uterine incision to birth (sec), duration of anesthesia (min), and duration of surgery (min) will be recorded.	Time between induction of spinal anesthesia until end of the anesthesia. Participants will be followed for the duration of hospital stay, an expected average of two days.	No
Primary	Maternal hypotension.	Maternal hypotension will be defined as at least a single administration of ephedrine within the period from induction of SA to the delivery (umbilical cord clamping). After spinal anesthesia, SAP will be measured and recorded at every minute until birth and every three minutes thereafter.	Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.	No
Primary	Incidence of severe hypotension.	Incidence of severe hypotension (SAP < 70% of the baseline value or SAP < 80 mmHg) will be recorded.	Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.	No
Primary	Cumulative duration of hypotension.	Cumulative duration of hypotension will be recorded from induction of spinal anesthesia until delivery (umbilical cord clamping).	Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.	No
Primary	Heart rate.	Minimum and maximum heart rate, bradycardia, atropine usage will be recorded.	Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.	No
Secondary	Neonatal effects.	Arterial and venous blood gas analyses will be performed from the umbilical cord after the cord clamped.	Time just after delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.	No
Secondary	Ephedrine treatment.	If SAB < 100 mmHg; patients will be treated by 5 mg IV bolus ephedrine, if SAB < 90 mmHg; patients will be treated by 10 mg IV bolus ephedrine.	Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.	No
Secondary	Nausea and/or vomiting.	Incidence of nausea and/or vomiting, incidence of prepartum nausea and/or vomiting will be recorded.	Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.	No