ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia
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Purpose
The purpose of this trial is to determine the effective volume of hydroxyethylstarch 130/0.4 which would prevent the occurence of maternal hypotension in 50% of healthy pregnant women undergoing a cesarean section under spinal anesthesia.
| Condition | Intervention | Phase |
|---|---|---|
|
Obstetric Anesthesia Spinal Anesthesia Hypotension Fluid Therapy Cesarean Section |
Drug: Hydroxyethylstarch 130/0.4 |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia |
- Volume of HES which will prevent hypotension if 50 % of the subjects. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Incidence of hypotension episodes [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
- Incidence of hypertensive episodes [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
- cardiac output [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
- Apgar score [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
- umbilical artery pH [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
- additional vasopressors administered [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Hydroxyethylstarch 130/0.4 |
Drug: Hydroxyethylstarch 130/0.4
first patient : 500 mL. Following volumes according to up-down sequential allocation, with increments or decrements of 100 mL. An absence of hypotension will lead to an decrement while a presence of hypotension will result in an increment.
Other Name: Voluven
|
Detailed Description:
The incidence of spinal anesthesia-induced hypotension in pregnant women undergoing a cesarean section is high. A preoperative fluid bolus of undetermined volume is frequently administered to lower the incidence of maternal hypotension, with a somewhat poor efficacy. Recently, several investigations have shown that the use of a phenylephrine infusion after the induction of spinal anesthesia results in a significant reduction in hypotensive episodes. Given the high efficacy of this therapy (incidence of hypotension around 20%), it is possible to determine the effective volume of fluid which would prevent hypotension in 50% of the patients studied (ED50).
Healthy term pregnant women undergoing elective cesarean section under spinal anesthesia will be recruited in this trial. The spinal anesthesia regimen will be standardized and all subjects will receive a phenylephrine infusion. The fluid investigated is hydroxyethylstarch (HES) 130/0.4 (Volulyte(R)). The ED50 will be determined using an up-down sequential allocation method initially described by Dixon & Massey. The determination of the HES ED50 will help the anesthesiologist in further treating maternal hypotension appropriately.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Healthy pregnant women (ASA I or II)
- Normal pregnancy
- Term gestation (37 weeks and above)
- Elective cesarean section
- Spinal anesthesia
Exclusion Criteria:
- Cardiopathies
- Hypertensive disease/ pre-eclampsia / eclampsia
- Any contraindication to neuraxial anesthesia
- Patient refusal
- Body mass index > 30 at first antenatal visit and > 32 at cesarean section
- Twin pregnancy
- Known allergies to HES
- Emergency cesarean section
Contacts and Locations| Contact: Christian Loubert, MD, FRCPC | 514.252.3426 | loubertch@yahoo.fr |
| Contact: Louis-Philippe Fortier, MD, FRCPC | 514.252.3426 | lpfortier@mac.com |
| Canada, Quebec | |
| Maisonneuve-Rosemont Hospital | Recruiting |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Contact: Christian Loubert, MD, FRCPC 514.252.3426 loubertch@yahoo.fr | |
| Contact: Louis-Philippe Fortier, MD, FRCPC 514.252.3426 lpfortier@mac.com | |
| Principal Investigator: Christian Loubert, MD, FRCPC | |
| Sub-Investigator: Pierre-Olivier Gagnon, MD | |
| Sub-Investigator: Louis-Philippe Fortier, MD, FRCPC | |
| Sub-Investigator: Pierre Drolet, MD,FRCPC | |
| Principal Investigator: | Christian Loubert, MD, FRCPC | Maisonneuve-Rosemont Hospital |
More Information
No publications provided
| Responsible Party: | Christian Loubert, Dr, Maisonneuve-Rosemont Hospital |
| ClinicalTrials.gov Identifier: | NCT01415284 History of Changes |
| Other Study ID Numbers: | LoubertHMR2011/01 |
| Study First Received: | August 10, 2011 |
| Last Updated: | February 12, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Maisonneuve-Rosemont Hospital:
|
Obstetric anesthesia Spinal anesthesia Hypotension Fluid therapy |
Cesarean section phenylephrine cardiac output |
Additional relevant MeSH terms:
|
Hypotension Vascular Diseases Cardiovascular Diseases Anesthetics Hetastarch Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Plasma Substitutes Blood Substitutes Hematologic Agents |
ClinicalTrials.gov processed this record on June 18, 2013