Comparative Analytical Study of Intravenous Bolus Dose of Mephentermine and Phenylephrine for Hemodynamic Stability During Elective Cesarean Section Under Spinal Anesthesia at KIST Medical College and Teaching Hospital

NCT05706727 | Completed Phase 3 DMC

• 1 other identifier: KISTMTH 01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Hemodynamics changes with spinal anesthesia is mainly due to sympathetic block which causes mainly hypotension \& bradycardia. Post spinal hypotension usually leads to various adverse maternal and fetal outcomes. Hence, effective prevention and treatment of maternal hypotension is of great clinical significance. Various studies have been done for the prevention of subarachnoid block induced hypotension but the optimal choice of vasopressors for the maintenance of hemodynamic stability during cesarean under spinal anesthesia is still unclear. The ideal vasopressor would be the one which is reliable and easy to use , has rapid onset, short duration of action, easily tritatable, can potentially be used prophylactically and lack any adverse maternal and fetal impact. Thus, aim of study is to compare the hemodynamic stability of mephenterime and phenylephrine during elective cesarean section under spinal anesthesia. The methodology of the study will be prospective, randomized double blinded study where patient meeting inclusion criteria for the study is divided into two groups ( Group M n=21) and ( Group P n= 21) i.e. Group M receives intravenous bolus of mephentermine 6mg and intravenous bolus of 50mcg. Hemodynamics changes in blood pressure and heart rate will monitored and compared among the study groups receiving intravenous boluses of study drugs. Data will be collected in proforma and saved by entering in the MS- EXCEL as well. Data will be analyzed using the statistical package for the social sciences (SPSS) version 27. The categorical data will be analyzed with Chi-square test and numerical variables of hemodynamic parameters between the study groups will be analyzed using student t- test. P-value \< 0.05 will be considered statistically significant. Hence, mephenterime and phenylephrine effectiveness will be studied for hemodynamic stability during cesarean section under spinal anesthesia

Conditions

Hemodynamic Stability

Outcome Measures

Primary Outcomes (1)

• To compare the intravenous bolus dose of mephentermine and phenylephrine for hemodynamic stability during elective cesarean section under spinal anesthesia

  To measure systolic blood pressure ( SBP) and diastolic blood pressure ( DBP) of the study groups

  6 months

Secondary Outcomes (2)

• To measure Mean Arterial Pressure ( MAP ) of study groups

  6 months

• To measure heart rate ( HR) of study group

  6 months

Study Arms (2)

Mephentermine ( M group)

EXPERIMENTAL

Group M

Drug: Intravenous bolus dose of Mephentermine and mephentermine

Phenylephrine ( P group )

EXPERIMENTAL

Group P

Drug: intravenous bolus dose of phenylephrine 50 mcg

Interventions

Intravenous bolus dose of Mephentermine and mephentermine DRUG

intravenous bolus dose of mephenteramine 6mg

Also known as: Mephentermine

Mephentermine ( M group)

intravenous bolus dose of phenylephrine 50 mcg DRUG

intravenous bolus dose of phenylephrine 50 mcg

Also known as: Phenylephrine

Phenylephrine ( P group )

Eligibility Criteria

• Age: 18 Years - 48 Years
• Gender Eligibility Details: All parturient meeting the study inclusion criteria and receiving sub-arachnoid block for undergoing elective cesarean section at KIST MEDICAL COLLEGE AND TEACHING HOSPITAL
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient undergoing elective cesarean section under spinal anesthesia
• Age between 18-48 years
• ASA class II ( all pregnant are categorized as ASA II)

You may not qualify if:

• Patient refusal
• Contraindication to spinal anesthesia like coagulation disorder , localized infection , sepsis, raised intracranial pressure etc
• Patchy spinal block , failed spinal block converting to GA
• Hypersensitivity to any drugs
• High Risk Pregnancy ( preeclampsia, eclampsia, preterm, Gestational Diabetes , etc )

Sponsors & Collaborators

• KIST Medical and Teaching Hospital: lead
• Nepal Health Research Council: collaborator

Study Sites (1)

KIST Medical and Teaching Hospital

Lalitpur, 56900, Nepal

Location

Related Publications (9)

• Habib AS. A review of the impact of phenylephrine administration on maternal hemodynamics and maternal and neonatal outcomes in women undergoing cesarean delivery under spinal anesthesia. Anesth Analg. 2012 Feb;114(2):377-90. doi: 10.1213/ANE.0b013e3182373a3e. Epub 2011 Nov 21.

  PMID: 22104076 BACKGROUND

• Klohr S, Roth R, Hofmann T, Rossaint R, Heesen M. Definitions of hypotension after spinal anaesthesia for caesarean section: literature search and application to parturients. Acta Anaesthesiol Scand. 2010 Sep;54(8):909-21. doi: 10.1111/j.1399-6576.2010.02239.x. Epub 2010 Apr 23.

  PMID: 20455872 BACKGROUND

• Corke BC, Datta S, Ostheimer GW, Weiss JB, Alper MH. Spinal anaesthesia for Caesarean section. The influence of hypotension on neonatal outcome. Anaesthesia. 1982 Jun;37(6):658-62. doi: 10.1111/j.1365-2044.1982.tb01278.x.

  PMID: 7091625 BACKGROUND

• Ohpasanon P, Chinachoti T, Sriswasdi P, Srichu S. Prospective study of hypotension after spinal anesthesia for cesarean section at Siriraj Hospital: incidence and risk factors, Part 2. J Med Assoc Thai. 2008 May;91(5):675-80.

  PMID: 18672631 BACKGROUND

• Campagna JA, Carter C. Clinical relevance of the Bezold-Jarisch reflex. Anesthesiology. 2003 May;98(5):1250-60. doi: 10.1097/00000542-200305000-00030. No abstract available.

  PMID: 12717149 BACKGROUND

• Mohta M, Janani SS, Sethi AK, Agarwal D, Tyagi A. Comparison of phenylephrine hydrochloride and mephentermine sulphate for prevention of post spinal hypotension. Anaesthesia. 2010 Dec;65(12):1200-5. doi: 10.1111/j.1365-2044.2010.06559.x.

  PMID: 21182601 BACKGROUND

• Mahajan L, Anand LK, Gombar KK. A randomized double-blinded comparison of ephedrine, phenylephrine and mephentermine infusions to maintain blood pressure during spinal anaesthesia for cesarean delivery: The effects on fetal acid-base status and haemodynamic control. J Anaesthesiol Clin Pharmacol. 2009;25(4):427-32.

  BACKGROUND

• Chandak A V., Bhuyan D, Singam AP, Patil B. Comparison of bolus phenylephrine, ephedrine and mephentermine for maintenance of arterial pressure during spinal anaesthesia in caesarean section. Res J Pharm Technol. 2021;14(3):1349-52.

  BACKGROUND

• Nag DS, Samaddar DP, Chatterjee A, Kumar H, Dembla A. Vasopressors in obstetric anesthesia: A current perspective. World J Clin Cases. 2015 Jan 16;3(1):58-64. doi: 10.12998/wjcc.v3.i1.58.

  PMID: 25610851 BACKGROUND

MeSH Terms

Interventions

Mephentermine; Phenylephrine

Intervention Hierarchy (Ancestors)

Phentermine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Ethanolamines; Amino Alcohols; Alcohols

Study Officials

• Dr. Smriti Koirala, MD

  KIST Medical College and Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients will be randomly allocated to the two groups of study by sealed envelope method. Group M patients who will receive intravenous bolus dose of mephentermine 6mg and Group P who will receive intravenous bolus dose of phenylephrine 50 mcg The drug preparations phenylephrine 50mcg/ml and mephenterime 6mg/ml will be done and labelled with code numbers by anesthesia assistant for all the patient and it is provided to anesthesiologist for administration who is not involved in the study as they will not be actively involved in the study nor in the patient care. The other anesthesia assistant or intern will be monitoring and recording information on proformas. Therefore investigator and participant of the study were blinded to the study drugs.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate

Model Details: Comparative Interventional

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: January 31, 2023
• Study Start: March 23, 2023
• Primary Completion: April 29, 2024
• Study Completion: May 15, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)