Anxiety and Phenylephrine Dosage a Prospective Observational Study.
| Tracking Information | |||
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| First Submitted Date ICMJE | October 3, 2018 | ||
| First Posted Date ICMJE | October 5, 2018 | ||
| Last Update Posted Date | October 5, 2018 | ||
| Actual Study Start Date ICMJE | October 20, 2018 | ||
| Estimated Primary Completion Date | October 20, 2019 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
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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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Anxiety and Phenylephrine Dosage a Prospective Observational Study. |
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| Official Title ICMJE | The Effect of Preoperative Anxiety on Phenylephrine Dosage During Cesarean Delivery Under Spinal Anesthesia, A Prospective Observational Study. |
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| Brief Summary | 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 we showed that preoperative anxiety assessed by VAS had a significant effect on hypotension after spinal anesthesia (8). Study objective: In this study we aim to evaluate the effect of anxiety on the cumulative phenylephrine dosage in women undergoing cesarean delivery under spinal anesthesia with prophylactic phenylephrine infusion. Our 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). |
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| Detailed Description | 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. In the operating room, spinal anesthesia will perform according to the standardized departmental protocol at the presumed L3-L4 or L4-L5 interspace with the patient in the sitting position. Hyperbaric bupivacaine 12 mg along with fentanyl 20 mcg and preservative-free morphine 100 mcg will be injected intrathecally in a total volume of 2.4 ml, via 25 or 26 Gauge needle. Patients will be placed immediately in a supine position with left uterine displacement. A further bolus of 500 ml of Lactated Ringer's solution will be administered over the next 30 min, during positioning and during and immediately after spinal anesthesia administration. 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. Inclusion criteria: Two hundred healthy term parturients, over 18 years old, with healthy singleton pregnancy, undergoing cesarean delivery under spinal anesthesia in Beilinson Hospital, following obtaining written informed consents forums with the ability to comply with the study requirements will be included in our study. Exclusion criteria: The following parturients will be excluded from study participation: 1. Women in active labor 2. Women with a twin pregnancy 3. Women with chronic hypertension or hypertension or preeclampsia. 4. Active medical or psychiatric disorders requiring regular medication. 5. Women who have any contraindication for spinal anesthesia. | ||
| Study Type ICMJE | Observational | ||
| Study Phase | |||
| Study Design ICMJE | Allocation: Intervention Model: Intervention Model Description: Masking: Observational Masking Description: Primary Purpose: |
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| Intervention ICMJE |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
100 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | October 20, 2019 | ||
| Estimated Primary Completion Date | October 20, 2019 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria: Two hundred healthy term parturients, over 18 years old, with healthy singleton pregnancy, undergoing cesarean delivery under spinal anesthesia in Beilinson Hospital, following obtaining written informed consents forums with the ability to comply with the study requirements will be included in our study. Exclusion Criteria: The following parturients will be excluded from study participation: 1. Women in active labor 2. Women with a twin pregnancy 3. Women with chronic hypertension or hypertension or preeclampsia. 4. Active medical or psychiatric disorders requiring regular medication. 5. Women who have any contraindication for spinal anesthesia. | ||
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | Israel | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | No | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | sharonorbach，Rabin Medical Center | ||
| Study Sponsor ICMJE | Rabin Medical Center | ||
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| PRS Account | Rabin Medical Center | ||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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