Phenylephrine vs. Norepinephrine Infusion After Spinal Anesthesia for Cesarean Delivery

NCT02354833 | Completed Phase 4 Results

• 1 other identifier: 1406316590
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine if a medication called phenylephrine, which helps to control blood pressure, is more effective as a continuous intravenous (IV) infusion compared to continuous IV norepinephrine in maintaining blood pressure during a spinal anesthetic for a cesarean delivery. Good blood pressure control has been shown to decrease nausea and vomiting during and after cesarean delivery under spinal anesthesia. For elective cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and morphine (provides long term pain control after cesarean delivery). This study plans to enroll 80 pregnant research subjects 18 years and above. Patients will be randomly assigned according to a computer generated system to be in one of two groups.

Conditions

Effects of; Anesthesia, in Labor and Delivery

Keywords

Hypotension; Cesarean Delivery; Phenylephrine; Spinal Anesthesia; Norepinephrine

Outcome Measures

Primary Outcomes (3)

• Number of Rescue Boluses to Maintain SBP

  Number of rescue boluses to maintain the SBP within 100-120% of baseline

  At time of surgery, up to 2 hours

• Median Total Rescue Bolus Dose of Ephedrine (mg) to Maintain SBP

  At time of surgery, up to 2 hours

• Median Total Rescue Bolus Dose of Phenylephrine (mcg) to Maintain SBP

  At time of surgery, up to 2 hours

Secondary Outcomes (1)

• Percentage of Participants Experiencing Both Nausea and Emesis

  At time of surgery, up to 2 hours

Study Arms (2)

Phenylephrine

EXPERIMENTAL

A continuous phenylephrine infusion at 0.1 mcg/kg/min

Drug: Phenylephrine

Norepinephrine

EXPERIMENTAL

A continuous norepinephrine infusion at 0.05 mcg/kg/min

Drug: Norepinephrine

Interventions

Phenylephrine DRUG

Phenylephrine

Norepinephrine DRUG

Also known as: Levophed

Norepinephrine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The American Society of Anesthesiologists (ASA) Physical Status classification 1 and 2
• Pregnant women with singleton pregnancy
• Gestational age greater than 36 weeks
• Cesarean delivery under spinal anesthesia

You may not qualify if:

• Use of cardiac medication or medication for blood pressure control
• Cardiovascular disease
• Multiple gestation
• Gestation diabetes requiring insulin
• History of postoperative nausea and vomiting
• Refusal to be in study
• Gastric bypass surgery
• History of chronic opioid use (chronic pain syndrome)
• Emergent caesarean delivery for maternal and/or fetal distress
• Eclampsia
• Progressive neurologic disease
• Infection at insertion site
• Allergy to local anesthetics, narcotics or other study medications.

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

Location

Related Publications (9)

• Afolabi BB, Lesi FE. Regional versus general anaesthesia for caesarean section. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD004350. doi: 10.1002/14651858.CD004350.pub3.

  PMID: 23076903 BACKGROUND

• Djabatey EA, Barclay PM. Difficult and failed intubation in 3430 obstetric general anaesthetics. Anaesthesia. 2009 Nov;64(11):1168-71. doi: 10.1111/j.1365-2044.2009.06060.x.

  PMID: 19825049 BACKGROUND

• Ohpasanon P, Chinachoti T, Sriswasdi P, Srichu S. Prospective study of hypotension after spinal anesthesia for cesarean section at Siriraj Hospital: incidence and risk factors, Part 2. J Med Assoc Thai. 2008 May;91(5):675-80.

  PMID: 18672631 BACKGROUND

• Lin FQ, Qiu MT, Ding XX, Fu SK, Li Q. Ephedrine versus phenylephrine for the management of hypotension during spinal anesthesia for cesarean section: an updated meta-analysis. CNS Neurosci Ther. 2012 Jul;18(7):591-7. doi: 10.1111/j.1755-5949.2012.00345.x.

  PMID: 22759268 BACKGROUND

• Lee A, Ngan Kee WD, Gin T. A quantitative, systematic review of randomized controlled trials of ephedrine versus phenylephrine for the management of hypotension during spinal anesthesia for cesarean delivery. Anesth Analg. 2002 Apr;94(4):920-6, table of contents. doi: 10.1097/00000539-200204000-00028.

  PMID: 11916798 BACKGROUND

• Stewart A, Fernando R, McDonald S, Hignett R, Jones T, Columb M. The dose-dependent effects of phenylephrine for elective cesarean delivery under spinal anesthesia. Anesth Analg. 2010 Nov;111(5):1230-7. doi: 10.1213/ANE.0b013e3181f2eae1. Epub 2010 Sep 14.

  PMID: 20841418 BACKGROUND

• Allen TK, George RB, White WD, Muir HA, Habib AS. A double-blind, placebo-controlled trial of four fixed rate infusion regimens of phenylephrine for hemodynamic support during spinal anesthesia for cesarean delivery. Anesth Analg. 2010 Nov;111(5):1221-9. doi: 10.1213/ANE.0b013e3181e1db21. Epub 2010 May 21.

  PMID: 20495139 BACKGROUND

• Ngan Kee WD, Khaw KS, Ng FF. Comparison of phenylephrine infusion regimens for maintaining maternal blood pressure during spinal anaesthesia for Caesarean section. Br J Anaesth. 2004 Apr;92(4):469-74. doi: 10.1093/bja/aeh088. Epub 2004 Feb 20.

  PMID: 14977792 BACKGROUND

• Doherty A, Ohashi Y, Downey K, Carvalho JC. Phenylephrine infusion versus bolus regimens during cesarean delivery under spinal anesthesia: a double-blind randomized clinical trial to assess hemodynamic changes. Anesth Analg. 2012 Dec;115(6):1343-50. doi: 10.1213/ANE.0b013e31826ac3db. Epub 2012 Sep 25.

  PMID: 23011562 BACKGROUND

MeSH Terms

Conditions

Hypotension

Interventions

Phenylephrine; Norepinephrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

38 subjects were enrolled in the phenylephrine group and none excluded. 47 subjects were enrolled in the norepinephrine group; 4 patients excluded (2 patients due to monitoring equipment failure, and 2 patients due to emergency cesarean deliveries).

Results Point of Contact

• Title: Dr. Manuel C. Vallejo, Chair of Department of Anesthesiology
• Organization: West Virginia University

mvallejo@wvumediciane.org

304-598-4929

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair; Professor

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: February 3, 2015
• Study Start: August 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 4, 2017
• Results First Posted: January 4, 2017

Record last verified: 2017-01

Locations

US (1)