Cesarean Delivery
Conditions
Keywords
Nausea, Vomiting
Brief summary
The study investigates the incidence of intraoperative nausea and vomiting under spinal anesthesia using a phenylephrine infusion with and without prophylactic antiemetics.
Interventions
DRUGMetoclopramide
Prophylactic Metoclopramide 10 mg given before spinal together with prophylactic phenylephrine infusion
Prophylactic phenylephrine infusion after spinal and placebo antiemetics
Metoclopramide and ondansetron prophylaxis with phenylephrine infusion
Sponsors
IWK Health Centre
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* English speaking ASA I-II non-laboring women with single gestations ≥36 weeks * Scheduled or unscheduled cesarean delivery under spinal anesthesia * Height: 5 feet-5 feet 11 in.
Exclusion criteria
* Laboring women needing an emergency cesarean delivery * Subjects less than 18 years of age * Receipt of a drug with antiemetic properties in the 24 hours prior to cesarean section * Allergy to ondansetron, or metoclopramide * Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP)\>160mmHg, diastolic blood pressure (DBP)\>110mmHg requiring antihypertensive treatment or associated with significant proteinuria. * Severe Cardiac disease in pregnancy with marked functional limitations * Diabetes type I * Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants * Morbid obesity (body mass index (BMI)\>45) * Inclusion in another anesthetic study involving drug administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Nausea and Vomiting | Intraoperatively | Comparison of intraoperative nausea and vomiting between the 3 groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Nausea and Vomiting (PONV) | 0-2h, 2-6h, 6-24h | — |
| Pruritus | 0-24 hrs | — |
| Satisfaction | 24 h | 1=very satisfied, 2=somewhat satisfied, 3= neither satisfied nor dissatisfied, 4=somewhat dissatisfied, 5= very dissatisfied. Number of very satisfied subjects posted. |
| Maternal Hemodynamics | Intraoperatively | The number of patients with systolic blood pressure decrease to less than 20 % of baseline intraoperatively |
Countries
United States
Participant flow
Recruitment details
December 2008-January 2011, University Medical Center
Participants by arm
| Arm | Count |
|---|---|
| Combination Group Metoclopramide and Ondansetron prophylaxis
Combination Group : Metoclopramide and ondansetron prophylaxis | 103 |
| Metoclopramide Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal | 100 |
| Phenylephrine Infusion Prophylactic phenylephrine infusion and placebo antiemetics
Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal | 103 |
| Total | 306 |
Baseline characteristics
| Characteristic | Combination Group | Metoclopramide | Phenylephrine Infusion | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 103 Participants | 100 Participants | 103 Participants | 306 Participants |
| Age, Continuous | 31 years STANDARD_DEVIATION 6 | 31 years STANDARD_DEVIATION 5 | 32 years STANDARD_DEVIATION 6 | 31 years STANDARD_DEVIATION 6 |
| Region of Enrollment Canada | 48 participants | 48 participants | 45 participants | 141 participants |
| Region of Enrollment United States | 55 participants | 52 participants | 58 participants | 165 participants |
| Sex: Female, Male Female | 103 Participants | 100 Participants | 103 Participants | 306 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 101 | 0 / 99 | 0 / 100 |
| serious Total, serious adverse events | 0 / 101 | 0 / 99 | 0 / 100 |
Outcome results
Primary
Intraoperative Nausea and Vomiting
Comparison of intraoperative nausea and vomiting between the 3 groups.
Time frame: Intraoperatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combination Group | Intraoperative Nausea and Vomiting | 23 participants |
| Metoclopramide | Intraoperative Nausea and Vomiting | 31 participants |
| Phenylephrine Infusion | Intraoperative Nausea and Vomiting | 49 participants |
Secondary
Maternal Hemodynamics
The number of patients with systolic blood pressure decrease to less than 20 % of baseline intraoperatively
Time frame: Intraoperatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combination Group | Maternal Hemodynamics | 16 participants with SBP< 20 % baseline |
| Metoclopramide | Maternal Hemodynamics | 19 participants with SBP< 20 % baseline |
| Phenylephrine Infusion | Maternal Hemodynamics | 16 participants with SBP< 20 % baseline |
Secondary
Postoperative Nausea and Vomiting (PONV)
Time frame: 0-2h, 2-6h, 6-24h
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combination Group | Postoperative Nausea and Vomiting (PONV) | 2-6 hrs PONV | 28 participants |
| Combination Group | Postoperative Nausea and Vomiting (PONV) | 0-2 hrs PONV | 20 participants |
| Combination Group | Postoperative Nausea and Vomiting (PONV) | 6-24 hrs PONV | 22 participants |
| Metoclopramide | Postoperative Nausea and Vomiting (PONV) | 2-6 hrs PONV | 35 participants |
| Metoclopramide | Postoperative Nausea and Vomiting (PONV) | 0-2 hrs PONV | 33 participants |
| Metoclopramide | Postoperative Nausea and Vomiting (PONV) | 6-24 hrs PONV | 26 participants |
| Phenylephrine Infusion | Postoperative Nausea and Vomiting (PONV) | 0-2 hrs PONV | 39 participants |
| Phenylephrine Infusion | Postoperative Nausea and Vomiting (PONV) | 6-24 hrs PONV | 22 participants |
| Phenylephrine Infusion | Postoperative Nausea and Vomiting (PONV) | 2-6 hrs PONV | 41 participants |
Secondary
Pruritus
Time frame: 0-24 hrs
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combination Group | Pruritus | 95 participants |
| Metoclopramide | Pruritus | 93 participants |
| Phenylephrine Infusion | Pruritus | 97 participants |
Secondary
Satisfaction
1=very satisfied, 2=somewhat satisfied, 3= neither satisfied nor dissatisfied, 4=somewhat dissatisfied, 5= very dissatisfied. Number of very satisfied subjects posted.
Time frame: 24 h
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combination Group | Satisfaction | 94 participants |
| Metoclopramide | Satisfaction | 85 participants |
| Phenylephrine Infusion | Satisfaction | 87 participants |