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ED95 of phenylephrine to prevent spinal-induced hypotension and/or nausea at elective cesarean delivery.
Int J Obstet Anesth. 2009 Apr; 18(2):125-30.IJ

Abstract

BACKGROUND

The purpose of this trial was to determine the 95% effective dose (ED95) of phenylephrine by intermittent i.v. bolus, to prevent spinal-induced hypotension and/or nausea at elective cesarean delivery.

METHODS

The study was conducted in a double-blinded fashion in 50 patients undergoing elective cesarean delivery under spinal anesthesia. The dose of phenylephrine was determined using up-down sequential allocation, modified by a variation of the Narayana rule. Systolic pressure and heart rate were assessed every minute until uterine incision. The first patient was assigned a 40-microg dose, and the dose to subsequent patients varied by 10-microg increments or decrements. An adequate response was defined as absence of hypotension (systolic pressure <80% of baseline) and nausea. The study solution was given immediately after spinal administration, without prior pressure measurement, and thereafter when the systolic pressure was <or=control values. fell below baseline. The ED95 was determined by a logistic model with non-log-transformed doses, using Firth's penalized maximum likelihood method with 95% confidence intervals based on penalized profile likelihood.

RESULTS

The ED95 of phenylephrine was estimated as 159 microg (95% confidence interval: 122-371 microg), although the largest dose given in the study was only 120 microg. Hypertension (systolic blood pressure >120% of baseline) was observed in 14 cases, immediately after intrathecal injection and prophylactic phenylephrine administration in all cases.

CONCLUSION

The ED95 of phenylephrine, administered as intermittent boluses to prevent pre-delivery spinal-induced hypotension and/or nausea at elective cesarean delivery, is at least 122 microg (lower limit of the confidence interval). The safety of this dose warrants further studies.

Authors+Show Affiliations

Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

19162468

Citation

Tanaka, M, et al. "ED95 of Phenylephrine to Prevent Spinal-induced Hypotension And/or Nausea at Elective Cesarean Delivery." International Journal of Obstetric Anesthesia, vol. 18, no. 2, 2009, pp. 125-30.
Tanaka M, Balki M, Parkes RK, et al. ED95 of phenylephrine to prevent spinal-induced hypotension and/or nausea at elective cesarean delivery. Int J Obstet Anesth. 2009;18(2):125-30.
Tanaka, M., Balki, M., Parkes, R. K., & Carvalho, J. C. (2009). ED95 of phenylephrine to prevent spinal-induced hypotension and/or nausea at elective cesarean delivery. International Journal of Obstetric Anesthesia, 18(2), 125-30. https://doi.org/10.1016/j.ijoa.2008.09.008
Tanaka M, et al. ED95 of Phenylephrine to Prevent Spinal-induced Hypotension And/or Nausea at Elective Cesarean Delivery. Int J Obstet Anesth. 2009;18(2):125-30. PubMed PMID: 19162468.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - ED95 of phenylephrine to prevent spinal-induced hypotension and/or nausea at elective cesarean delivery. AU - Tanaka,M, AU - Balki,M, AU - Parkes,R K, AU - Carvalho,J C A, Y1 - 2009/01/21/ PY - 2008/09/28/accepted PY - 2009/1/24/entrez PY - 2009/1/24/pubmed PY - 2009/6/27/medline SP - 125 EP - 30 JF - International journal of obstetric anesthesia JO - Int J Obstet Anesth VL - 18 IS - 2 N2 - BACKGROUND: The purpose of this trial was to determine the 95% effective dose (ED95) of phenylephrine by intermittent i.v. bolus, to prevent spinal-induced hypotension and/or nausea at elective cesarean delivery. METHODS: The study was conducted in a double-blinded fashion in 50 patients undergoing elective cesarean delivery under spinal anesthesia. The dose of phenylephrine was determined using up-down sequential allocation, modified by a variation of the Narayana rule. Systolic pressure and heart rate were assessed every minute until uterine incision. The first patient was assigned a 40-microg dose, and the dose to subsequent patients varied by 10-microg increments or decrements. An adequate response was defined as absence of hypotension (systolic pressure <80% of baseline) and nausea. The study solution was given immediately after spinal administration, without prior pressure measurement, and thereafter when the systolic pressure was <or=control values. fell below baseline. The ED95 was determined by a logistic model with non-log-transformed doses, using Firth's penalized maximum likelihood method with 95% confidence intervals based on penalized profile likelihood. RESULTS: The ED95 of phenylephrine was estimated as 159 microg (95% confidence interval: 122-371 microg), although the largest dose given in the study was only 120 microg. Hypertension (systolic blood pressure >120% of baseline) was observed in 14 cases, immediately after intrathecal injection and prophylactic phenylephrine administration in all cases. CONCLUSION: The ED95 of phenylephrine, administered as intermittent boluses to prevent pre-delivery spinal-induced hypotension and/or nausea at elective cesarean delivery, is at least 122 microg (lower limit of the confidence interval). The safety of this dose warrants further studies. SN - 1532-3374 UR - https://www.unboundmedicine.com/medline/citation/19162468/ED95_of_phenylephrine_to_prevent_spinal_induced_hypotension_and/or_nausea_at_elective_cesarean_delivery_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0959-289X(08)00157-X DB - PRIME DP - Unbound Medicine ER -