Nausea, Vomiting
Conditions
Brief summary
In parturients undergoing Cesarean section under spinal anesthesia, co-loading of 1 liter of crystalloids, with placing the spinal, along with administering a phenylephrine infusion and glycopyrrolate, enables placing a spinal with minimal perioperative nausea and vomiting and good intra and post-operative pain relief.
Detailed description
The hypothesis of this study is as follows: In parturients undergoing Cesarean section under spinal anesthesia, co-loading of 1 liter of crystalloids, with placing the spinal, along with administering a phenylephrine infusion and glycopyrrolate, enables placing a spinal with minimal perioperative nausea and vomiting and good intra and post-operative pain relief. The study group will receive phenylephrine infusion \[dilution 100micrograms /cc\] Rate of infusion 50micrograms /hour, approximately 30ml/hour To be started immediately after the placement of the spinal anesthetic Patient will also be given .4mg \[1cc of glycopyrrolate\], with the starting of the infusion The control group, will receive phenylephrine infusion \[dilution 100micrograms /cc\] Rate of infusion 50micrograms /hour, approximately 30ml/hour To be started immediately after the placement of the spinal anesthetic Patient will also be given a placebo \[1cc of N saline\], with the starting of the infusion Following the administration of the study drug/placebo, the patient will be monitored for severity of nausea , vomiting and pain at 5 minutes intervals from placement of the spinal to delivery of the baby, and then at 15 minutes intervals from delivery of the baby till the end of the surgery ( the cesarean section)
Interventions
DRUGGlycopyrrolate
.2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose
DRUGNormal Saline
1ml of normal saline will be given intravenously with the administration of the spinal dose
Sponsors
Kokila N Thenuwara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Pregnant 2. American Society of Anesthesiologists risk classification I and II 3. Age \> 18 years 4. Non-laboring 5. Patients with elective cesarean sections
Exclusion criteria
1. Non- English speakers 2. Height \< 4' 11 3. BMI \>40 Kg/ mm 4. Antiemetic drug use in the 24 hours prior to cesarean delivery, 5. Hypertensive diseases of pregnancy 6. Chronic hypertension receiving antihypertensive treatment 7. Any other physical or psychiatric condition that may impair their ability to cooperate with study data collection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Reported Nausea | From the administration of the spinal anesthesia to delivery of baby - Total time 90minutes | Did the subject report nausea? The subject will respond with yes or no. |
| Number of Participants Who Experienced Vomiting. | From the administration of the spinal anesthesia to delivery of baby; Total time 90minutes | This measure is observed by care team. Reported as vomiting, yes or no. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo: Normal Saline 1ml of Normal Saline will be given intravenously with the administering of the spinal dose
Normal Saline: 1ml of normal saline will be given intravenously with the administration of the spinal dose | 11 |
| Glycopyrrolate Group 1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose
Glycopyrrolate: .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose | 11 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Other | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo: Normal Saline | Glycopyrrolate Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 11 Participants | 22 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
Number of Participants Who Experienced Vomiting.
This measure is observed by care team. Reported as vomiting, yes or no.
Time frame: From the administration of the spinal anesthesia to delivery of baby; Total time 90minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo: Normal Saline | Number of Participants Who Experienced Vomiting. | 4 Participants |
| Glycopyrrolate Group | Number of Participants Who Experienced Vomiting. | 2 Participants |
Primary
Number of Participants Who Reported Nausea
Did the subject report nausea? The subject will respond with yes or no.
Time frame: From the administration of the spinal anesthesia to delivery of baby - Total time 90minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo: Normal Saline | Number of Participants Who Reported Nausea | 8 Participants |
| Glycopyrrolate Group | Number of Participants Who Reported Nausea | 7 Participants |