Anxiety and Phenylephrine Dosage
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| ClinicalTrials.gov Identifier: NCT03696732 |
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Recruitment Status : Unknown
Verified September 2019 by sharonorbach, Rabin Medical Center.
Recruitment status was: Recruiting
First Posted : October 5, 2018
Last Update Posted : September 20, 2019
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Spinal anesthesia is considered gold standard anesthetic technique of choice for cesarean delivery (1). However its use is frequently associated with maternal hypotension, which occurs in up to 71% of cases, without prophylactic treatment(2) Spinal hypotension can lead to unpleasant maternal side effects such as nausea, vomiting and dizziness. In addition, adverse effects on the neonate occur because of reduced uteroplacental blood flow resulting in impaired fetal oxygenation and fetal acidosis. As such, current research recommends the prophylactic use of vasopressors for improved maternal and fetal outcomes(3).
The international consensus statement on the management of hypotension during cesarean delivery states, that a prophylactic phenylephrine infusion is superior to bolus administration and should be dose titrated according to blood pressure parameters (4). In according to the international guidelines, in our obstetric anesthesia unit, we use a standardized spinal anesthetic regime protocol with a standardized prophylactic phenylephrine infusion at a rate of 50 mcg/min, with the vasopressor dose titrated according to every minute blood pressure parameters.
Spinal anesthesia causes maternal hypotension, resulting from a blockade of sympathetic efferent neurons. Patients with higher baseline sympathetic activation have been known to have more marked hypotension after spinal anesthesia (5, 6) Anxiety causes generalized sympathetic activation (7). In a previous research the investigators showed that preoperative anxiety assessed by VAS had a significant effect on hypotension after spinal anesthesia (8).
Study objective:
In this study the investigators aim to evaluate the effect of anxiety on the cumulative phenylephrine dosage in women undergoing cesarean delivery under spinal anesthesia with prophylactic phenylephrine infusion. The primary hypothesis is that parturients who suffer from preoperative anxiety measured by a verbal numerical scale (VNS) anxiety score and Spielberger State-Trait Inventory questionnaire, will receive higher cumulative doses of phenylephrine (resulting from higher incidence of maternal hypotension).
| Condition or disease | Intervention/treatment |
|---|---|
| Phenylephrine | Other: Anxiety questionnaire Other: VAS questionnaire |
Methods:
This is a prospective, observational, single center study, which will be conducted at the Rabin Medical Center (Beilinson campus), Petach Tikva, Israel, a tertiary university hospital. This study Is a purely observational study, with no implication on the medical treatment provided.
Two hundred women aged 18 and above undergoing cesarean section delivery under spinal anesthesia will be enrolled after filling out an informed consent prior to surgery. Women will be requested to fill out an informed consent in the women's surgery waiting room on the day of surgery, when they aren't under any pain.
The parturients preoperative anxiety will be assessed in the women's waiting room, on the day of the surgery using two previously validated direct psychological measures of anxiety: verbal numerical scale (VNS) anxiety score (9, 10), and the Spielberger. State-Trait Inventory questionnaire (13).
Women will also be asked about nausea and vomiting during the surgery and in the post anesthesia care unit.
In according to standard departmental clinical practice, baseline blood pressure will be determined in the preoperative holding area by recording 3 times ≥ 3 minutes apart using an automated oscillometric blood pressure cuff on the arm with the patient supine with left uterine displacement, with the mean of the 3 values taken as a baseline systolic and diastolic blood pressure. Women will undergo spinal anesthesia and blood pressure will be measured evert minute during labor. Hypotension will be treated by titrating the phenylephrine infusion and by phenylephrine boluses, using a standardized algorithm according to departmental protocol. At the time of spinal injection, a phenylephrine infusion will be started at 50 mcg/min. The automated blood pressure cuff will be programmed to cycle each minute. When each new blood pressure result will appear, the phenylephrine infusion will be adjusted based on the systolic blood pressure by a standard algorithm.
Parturient's obstetric history, obstetric data and anesthetic data will be collected from each of the participant's medical file, in an anonymized way.
| Study Type : | Observational |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | The Effect of Preoperative Anxiety on Phenylephrine Dosage During Cesarean Delivery Under Spinal Anesthesia, A Prospective Observational Study. |
| Actual Study Start Date : | October 20, 2018 |
| Estimated Primary Completion Date : | October 20, 2019 |
| Estimated Study Completion Date : | October 20, 2019 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Women undergoing cesarean section
Women undergoing cesarean section under spinal anesthesia with prophylactic phenylephrine drip.
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Other: Anxiety questionnaire
Spielberger. State-Trait Inventory questionnaire Other: VAS questionnaire verbal numerical scale (VNS) anxiety score |
- Total cumulative phenylephrine dosage in women undergoing cesarean delivery under spinal anesthesia with prophylactic phenylephrine infusion. [ Time Frame: During surgery -2 hours ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Healthy parturients undergoing cesarean delivery under spinal anesthesia in Beilinson Hospital.
Exclusion Criteria:
- Women in active labor
- Women with a twin pregnancy
- Women with chronic hypertension or hypertension or preeclampsia.
- Active medical or psychiatric disorders requiring regular medication.
- Women who have any contraindication for spinal anesthesia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696732
| Israel | |
| Beilinson hospital | Recruiting |
| Petach tikvah, Israel | |
| Contact: Sharon Orbach, MD 972-54-538-3093 sharonorbach@yahoo.com | |
| Principal Investigator: Sharon Orbach-zinger | |
| Principal Investigator: Eran Danon | |
| Responsible Party: | sharonorbach, Associate Professor, Rabin Medical Center |
| ClinicalTrials.gov Identifier: | NCT03696732 |
| Other Study ID Numbers: |
450-18 |
| First Posted: | October 5, 2018 Key Record Dates |
| Last Update Posted: | September 20, 2019 |
| Last Verified: | September 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |