Colloid Preload Versus Colloid Coload During Cesarean Deliveries

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

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.

Study Overview

• Status: Unknown
• Conditions: Hypotension; Anesthesia; Adverse Effect, Spinal and Epidural
• Intervention / Treatment: Drug: hydroxyethyl starch (% 6 HES 130/0.4) (Voluven®); Drug: hydroxyethyl starch (%6 HES 130/0.4) (Voluven®)

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Aysun Afife Kar, MD; Phone Number: +905326521313; Email: aaysunkar@hotmail.com

Study Locations

• Turkey
  • İzmir, Turkey, 35100
    • Recruiting
    • Şifa Üniversitesi, Basmane Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Preloading (Group P); Group Preloading (Group P): 500 mL hydroxyethyl starch (6% HES 130/0.4) (Voluven®; Fresenius Kabi, Bad Homburg, Germany) will be infused via a pressure infusion system at a maximum speed as possible before spinal anesthesia.	Drug: hydroxyethyl starch (% 6 HES 130/0.4) (Voluven®); Before spinal anesthesia; Other Names: (Voluven®; Fresenius Kabi, Bad Homburg, Germany)
Active Comparator: Group Coloading (Group C); Group Coloading (Group C): After the patients have been monitored, spinal anesthesia will be performed. Recognizing the cerebrospinal fluid, 500 mL hydroxyethyl starch (%6 HES 130/0.4) (Voluven®; Fresenius Kabi, Bad Homburg, Germany) will be infused via a pressure infusion system at a maximum speed as possible.	Drug: hydroxyethyl starch (%6 HES 130/0.4) (Voluven®); Just after spinal anesthesia; Other Names: (Voluven®; Fresenius Kabi, Bad Homburg, Germany)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Sifa University
• Investigators: Principal Investigator: Aysun Afife Kar, MD, Şifa Üniversitesi, Basmane Hastanesi, İzmir, Turkey

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: March 1, 2015
• First Submitted That Met QC Criteria: March 15, 2015
• First Posted (Estimate): March 19, 2015

Study Record Updates

• Last Update Posted (Estimate): November 17, 2015
• Last Update Submitted That Met QC Criteria: November 16, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: colloid preloading; colloid coloading
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Plasma Substitutes; Blood Substitutes; Hydroxyethyl Starch Derivatives
• Other Study ID Numbers: SifaU