Title

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
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Status

    Unknown status
  • Intervention/Treatment

    hydroxyethyl starch ...
  • Study Participants

    200
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.
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 Started
Mar 31
2015
Primary Completion
Jan 31
2016
Anticipated
Study Completion
Mar 31
2016
Anticipated
Last Update
Nov 17
2015
Estimate

Drug hydroxyethyl starch (% 6 HES 130/0.4) (Voluven®)

Before spinal anesthesia

  • Other names: (Voluven®; Fresenius Kabi, Bad Homburg, Germany)

Drug hydroxyethyl starch (%6 HES 130/0.4) (Voluven®)

Just after spinal anesthesia

  • Other names: (Voluven®; Fresenius Kabi, Bad Homburg, Germany)

Group Preloading (Group P) Active Comparator

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.

Group Coloading (Group C) Active Comparator

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.

Criteria

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
No Results Posted