Trial Outcomes & Findings for Spinal Anesthesia Induced Hypotension During Cesarean Section (NCT NCT00846651)

NCT ID: NCT00846651

Last Updated: 2017-10-16

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 82 participants
• Primary outcome timeframe: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby
• Results posted on: 2017-10-16

Participant Flow

We applied for an IRB approval for 90 patients. The power analysis indicated that a minimum of 37 subjects for each group was needed. To allow for potential dropouts, we applied for 45 patient in each group. (total of 9O patients)

Participant milestones

Measure	Colloid, Then Phenylephrine Infusion colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.	Crystalloid, Then Phenylephrine Infusion Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
Overall Study STARTED	41	41
Overall Study COMPLETED	37	37
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Spinal Anesthesia Induced Hypotension During Cesarean Section

Baseline characteristics by cohort

Measure	Colloid, Then Phenylephrine Infusion n=41 Participants colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.	Crystalloid, Then Phenylephrine Infusion n=41 Participants Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.	Total n=82 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=93 Participants	41 Participants n=4 Participants	82 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	25.9 years STANDARD_DEVIATION 5.1 • n=93 Participants	28.3 years STANDARD_DEVIATION 5.9 • n=4 Participants	26.6 years STANDARD_DEVIATION 5.3 • n=27 Participants
Sex: Female, Male Female	41 Participants n=93 Participants	41 Participants n=4 Participants	82 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	41 participants n=93 Participants	41 participants n=4 Participants	82 participants n=27 Participants

PRIMARY outcome

Timeframe: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby

Outcome measures

Measure	Colloid, Then Phenylephrine Infusion n=37 Participants colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.	Crystalloid, Then Phenylephrine Infusion n=37 Participants Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
Incidence of Maternal Hypotension	10.8 percentage of participants	27 percentage of participants

SECONDARY outcome

Timeframe: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby

Outcome measures

Measure	Colloid, Then Phenylephrine Infusion n=37 Participants colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.	Crystalloid, Then Phenylephrine Infusion n=37 Participants Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
Dosage of Phenylephrine Used	1077 mcg of phenylephrine Standard Deviation 541	1477 mcg of phenylephrine Standard Deviation 591

SECONDARY outcome

Timeframe: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby

Outcome measures

Measure	Colloid, Then Phenylephrine Infusion n=37 Participants colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.	Crystalloid, Then Phenylephrine Infusion n=37 Participants Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
Incidence of Maternal Bradycardia	35.1 percentage of participants	45.8 percentage of participants

SECONDARY outcome

Timeframe: delivery of the baby

Population: Physician policy changes resulted in blood gas values not being ordered and thus data was not available for the outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Apgar scores were assessed at 1 amd 5 min after delivery of the baby

The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10 with higher scores being better than lower scores. The five criteria are summarized using words chosen to form an acronym (Appearance, Pulse, Grimace, Activity, Respiration).

Outcome measures

Measure	Colloid, Then Phenylephrine Infusion n=37 Participants colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.	Crystalloid, Then Phenylephrine Infusion n=37 Participants Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
APGAR Scores	9 units on a scale Interval 7.0 to 10.0	9 units on a scale Interval 8.0 to 10.0

SECONDARY outcome

Timeframe: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby

Outcome measures

Measure	Colloid, Then Phenylephrine Infusion n=37 Participants colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.	Crystalloid, Then Phenylephrine Infusion n=37 Participants Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
Incidence of Maternal Nausea and Vomiting	16.2 percentage of participants	18.9 percentage of participants

Adverse Events

Colloid, Then Phenylephrine Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Crystalloid, Then Phenylephrine Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sonia Vaida

Penn State Milton S. Hershey Medical Center

Phone: 7175318433

Email: svaida@hmc.psu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place