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Variable Rate Phenylephrine Infusion for Prevention of Spinal-induced Hypotension for Cesarean Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01378325
Recruitment Status : Completed
First Posted : June 22, 2011
Results First Posted : August 26, 2014
Last Update Posted : August 26, 2014
Sponsor:
Information provided by (Responsible Party):
Sahar Sayyid, American University of Beirut Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Anesthetic Complication Spinal
Interventions Drug: Phenylephrine
Drug: saline
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phenylephrine Saline
Hide Arm/Group Description

PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery

Phenylephrine: Prophylactic variable rate of phenylephrine infusion started at 0.75 µg/kg/min vs saline

crystalloid coload with lactated Ringer solution combined with prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
Period Title: Overall Study
Started 40 40
Completed 40 39
Not Completed 0 1
Reason Not Completed
Protocol Violation             0             1
Arm/Group Title Saline Phenylephrine Total
Hide Arm/Group Description Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery Total of all reporting groups
Overall Number of Baseline Participants 39 40 79
Hide Baseline Analysis Population Description
with β of 0.2 and α of 0.05 and two-sided test for comparing two means (http://www.stat.ubc.ca/~rollin/stats/ssize/n2.html), the calculated number of patients was 37 in each group.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 40 participants 79 participants
33.5  (5) 32.5  (5) 33  (5)
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number of Female Participants Number Analyzed 39 participants 40 participants 79 participants
39 40 79
[1]
Measure Description: Gender, female
1.Primary Outcome
Title Number of Physician Interventions Needed to Maintain Maternal Blood Pressure After Spinal Anesthesia Within 20% of Baseline and to Treat Bradycardia During Cesarean Delivery.
Hide Description

Physician interventions are triggered by hemodynamic changes more than 20% of baseline. The intervention can be one or more of the following:

  • stopping the phenylephrine infusion
  • changing the rate of phenylephrine infusion
  • rescue intravenous bolus of phenylephrine (100 µg) for hypotension
  • rescue intravenous bolus of atropine (0.4 mg) for bradycardia
Time Frame Patients will be followed up throughout the Cesarean delivery (average of 1.5 hours).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Saline
Hide Arm/Group Description:

PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery

Phenylephrine: Prophylactic variable rate of phenylephrine infusion started at 0.75 µg/kg/min vs saline

crystalloid coload with lactated Ringer solution combined with prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
Overall Number of Participants Analyzed 40 39
Median (Full Range)
Unit of Measure: number of interventions
0
(0 to 6)
3
(0 to 9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Saline Phenylephrine
Hide Arm/Group Description Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline Phenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery
All-Cause Mortality
Saline Phenylephrine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Saline Phenylephrine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/40 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Saline Phenylephrine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/40 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sahar Siddik-Sayyid
Organization: AUBMC
Phone: 9611350000 ext 6380
EMail: ss01@aub.edu.lb
Layout table for additonal information
Responsible Party: Sahar Sayyid, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT01378325    
Other Study ID Numbers: ANES.SS.10
First Submitted: June 10, 2011
First Posted: June 22, 2011
Results First Submitted: July 2, 2014
Results First Posted: August 26, 2014
Last Update Posted: August 26, 2014