Intramuscular Phenylephrine HCL for Prevention of Spinal Anesthesia Induced Hypotension

NCT05348980 | Completed Phase 4

• 1 other identifier: RMI/RMI-REC/Approval/57
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Spinal anesthesia (SA) is preferred over general anesthesia in Cesarean section (CS) due to its better safety profile but SA induced hypotension remains a big challenge for the clinical Anesthetist. Different methods including 15° left lateral table tilt, leftward uterine manual displacement, fluid pre-and co-loading have been used but drop in Systolic Blood Pressure (SBP) jeopardizing maternal and fetal well-being still occurs. Timely administered Phenylephrine HCL, an α-1 adrenergic agonist, is a recommended remedy. Subjects and methods: Sixty parturients of American Society of Anaesthesiologists (ASA) physical status 1 and 2, scheduled for elective CS under SA were enrolled in this prospective double-blinded study and randomly divided into two equal groups, P4 and P8. They received intramuscular (IM) Phenylephrine HCL 04 mg and 08 mg respectively before SA. Spinal block up to T6 was achieved with 12.5 mg 0.5% Bupivacaine HCl heavy. The incidence and intensity of hypotension, rescue doses of Phenylephrine HCL and any adverse event, were recorded. Data collected was analyzed using Epi lnfo ™ version 7.2.

Conditions

Hypotension; Anesthesia

Keywords

Cesarean section.

Outcome Measures

Primary Outcomes (1)

• Incidence of hypotension in both groups

  The primary outcome is to find incidence of hypotension in each group P4 and P8 i.e. number of participants who develop hypotension in the relevant group multiplied by 100. Incidence= number of participants who develop hypotension/ total participants in the group \*100. Hypotension is defined as a decrease of more than 20 % from baseline systolic blood pressure measured through non-invasive method.

  One and half hour post spinal anesthesia

Secondary Outcomes (4)

• To find the rescue dose/ doses of intravenous Phenylephrine HCL.

  One and half hour post spinal anesthesia

• Onset of hypotension

  Half hour/ 30 minutes post spinal anesthesia

• Adverse events associated with any groups

  One and half hour post spinal anesthesia

• Neonatal APGAR Score

  5 minutes post delivery

Study Arms (2)

Phenylephrine 4mg

ACTIVE COMPARATOR

Inj Phenylephrine HCL 04 mg as Group P4.

Drug: Phenylephrine Hydrochloride 4 mg

Phenylephrine 8mg

ACTIVE COMPARATOR

Inj Phenylephrine HCL 08 mg as Group P8.

Drug: Phenylephrine Hydrochloride 8 mg

Interventions

Phenylephrine Hydrochloride 4 mg DRUG

Intramuscular Phenylephrine HCL 04 mg were administered as prophylactic stat dose in Vastus lateralis muscle of thigh 05 minutes before giving spinal anesthesia.

Also known as: Injection Synephrine (Atco Laboratories Ltd. Pakistan

Phenylephrine 4mg

Phenylephrine Hydrochloride 8 mg DRUG

Intramuscular Phenylephrine HCL 08 mg were administered as prophylactic stat dose in Vastus lateralis muscle of thigh 05 minutes before giving spinal anesthesia.

Also known as: Injection Synephrine (Atco Laboratories Ltd. Pakistan

Phenylephrine 8mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All pregnant ladies of American Society of Anesthesiologists (ASA) physical status 1 or 2 with
• Singleton Pregnancy,
• Full term pregnancy, and
• Admitted for elective CS

You may not qualify if:

• All those participants having;
• Blood pressure ≥140/90 mm of Hg,
• ASA 3 or above status,
• Contraindication to spinal anesthesia
• Fetal anomalies/
• Abnormal placentae
• Refusal to consent

Sponsors & Collaborators

• Rehman Medical Institute - RMI: lead

Study Sites (1)

Rehman Medical Institute

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

Related Publications (15)

• Shitemaw T, Jemal B, Mamo T, Akalu L. Incidence and associated factors for hypotension after spinal anesthesia during cesarean section at Gandhi Memorial Hospital Addis Ababa, Ethiopia. PLoS One. 2020 Aug 13;15(8):e0236755. doi: 10.1371/journal.pone.0236755. eCollection 2020.

  PMID: 32790681 BACKGROUND

• Michelsen TM, Tronstad C, Rosseland LA. Blood pressure and cardiac output during caesarean delivery under spinal anaesthesia: a prospective cohort study. BMJ Open. 2021 Jun 14;11(6):e046102. doi: 10.1136/bmjopen-2020-046102.

  PMID: 34127491 BACKGROUND

• Richards E, Lopez MJ, Maani C V. Phenylephrine. xPharm Compr Pharmacol Ref [Internet]. 2021 Jul 13 [cited 2022 Jan 17];1-5. Available from: https://www.ncbi.nlm.nih.gov/books/NBK534801/

  BACKGROUND

• GBD 2015 Maternal Mortality Collaborators. Global, regional, and national levels of maternal mortality, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1775-1812. doi: 10.1016/S0140-6736(16)31470-2.

  PMID: 27733286 RESULT

• Amjad A, Imran A, Shahram N, Zakar R, Usman A, Zakar MZ, Fischer F. Trends of caesarean section deliveries in Pakistan: secondary data analysis from Demographic and Health Surveys, 1990-2018. BMC Pregnancy Childbirth. 2020 Dec 2;20(1):753. doi: 10.1186/s12884-020-03457-y.

  PMID: 33267787 RESULT

• Ferre F, Martin C, Bosch L, Kurrek M, Lairez O, Minville V. Control of Spinal Anesthesia-Induced Hypotension in Adults. Local Reg Anesth. 2020 Jun 3;13:39-46. doi: 10.2147/LRA.S240753. eCollection 2020.

  PMID: 32581577 RESULT

• Rijs K, Mercier FJ, Lucas DN, Rossaint R, Klimek M, Heesen M. Fluid loading therapy to prevent spinal hypotension in women undergoing elective caesarean section: Network meta-analysis, trial sequential analysis and meta-regression. Eur J Anaesthesiol. 2020 Dec;37(12):1126-1142. doi: 10.1097/EJA.0000000000001371.

  PMID: 33109924 RESULT

• EVALUATION OF PREEMPTIVE INTRAMUSCULAR EPHEDRINE VS PHENYLEPHRINE IN PREVENTION OF HYPOTENSION INDUCED BY SPINAL ANESTHESIA IN LOWER SEGMENT CAESAREAN SECTION. [cited 2021 Dec 18]; Available from: www.ijmedicines.com

  RESULT

• Ngan Kee WD, Lee SW, Ng FF, Tan PE, Khaw KS. Randomized double-blinded comparison of norepinephrine and phenylephrine for maintenance of blood pressure during spinal anesthesia for cesarean delivery. Anesthesiology. 2015 Apr;122(4):736-45. doi: 10.1097/ALN.0000000000000601.

  PMID: 25635593 RESULT

• Hasanin AM, Amin SM, Agiza NA, Elsayed MK, Refaat S, Hussein HA, Rouk TI, Alrahmany M, Elsayad ME, Elshafaei KA, Refaie A. Norepinephrine Infusion for Preventing Postspinal Anesthesia Hypotension during Cesarean Delivery: A Randomized Dose-finding Trial. Anesthesiology. 2019 Jan;130(1):55-62. doi: 10.1097/ALN.0000000000002483.

  PMID: 30335625 RESULT

• Wang X, Shen X, Liu S, Yang J, Xu S. The Efficacy and Safety of Norepinephrine and Its Feasibility as a Replacement for Phenylephrine to Manage Maternal Hypotension during Elective Cesarean Delivery under Spinal Anesthesia. Biomed Res Int. 2018 Dec 31;2018:1869189. doi: 10.1155/2018/1869189. eCollection 2018.

  PMID: 30687737 RESULT

• Xu C, Liu S, Qian D, Liu A, Liu C, Chen Y, Qi D. Preventive intramuscular phenylephrine in elective cesarean section under spinal anesthesia: A randomized controlled trial. Int J Surg. 2019 Feb;62:5-11. doi: 10.1016/j.ijsu.2018.12.014. Epub 2019 Jan 11.

  PMID: 30639574 RESULT

• Oh AY, Hwang JW, Song IA, Kim MH, Ryu JH, Park HP, Jeon YT, Do SH. Influence of the timing of administration of crystalloid on maternal hypotension during spinal anesthesia for cesarean delivery: preload versus coload. BMC Anesthesiol. 2014 May 16;14:36. doi: 10.1186/1471-2253-14-36. eCollection 2014.

  PMID: 24920942 RESULT

• Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.

  PMID: 29090733 RESULT

• Xu C, Liu S, Huang Y, Guo X, Xiao H, Qi D. Phenylephrine vs ephedrine in cesarean delivery under spinal anesthesia: A systematic literature review and meta-analysis. Int J Surg. 2018 Dec;60:48-59. doi: 10.1016/j.ijsu.2018.10.039. Epub 2018 Oct 31.

  PMID: 30389535 RESULT

MeSH Terms

Conditions

Hypotension

Interventions

Phenylephrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Mohammad Shafiq, FCPS

  Rehman Medical Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Two color coded envelops containing drug doses for intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: The study design was prospective double-blinded randomized parallel with allocation ratio of 1:1.

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 27, 2022
• Study Start: January 1, 2020
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: April, 2022 to April, 2025.
• Access Criteria: IPD will be shared on inter institutional request basis.

Locations

PA (1)