Norepinephrine Versus Phenylephrine for Preventing Spinal Anesthesia Induced Hypotension in Elderly

NCT04195321 | Completed Phase 4

• 1 other identifier: D-7-2019
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Various regimens were used for prevention of hypotension; most of these regimens included the use of vasopressors. Ephedrine is commonly used vasopressor for management and prophylaxis of hypotension; however, ephedrine is usually associated with tachycardia which increases oxygen consumption; thus, it might be potentially harmful in this special group of patients. Phenylephrine (PE) is another vasopressor which is characterized by α agonistic activity. PE had been the preferred vasopressor for prophylaxis against post-spinal hypotension especially in obstetric population. it was reported that PE improved the intraoperative hemodynamic profile in elderly patients undergoing lower extremities orthopedic surgery under spinal anesthesia. PE (a pure α agonist) was reported to decrease cardiac output which limit its use in patients with compromised cardiac contractility; this fact makes the use of PE in elderly patients questionable. Norepinephrine (NE) is characterized by α agonistic and weak β agonistic activity; thus, NE is characterized by less cardiac depression compared to PE. NE was recently introduced for prophylaxis against post-spinal hypotension in obstetric anesthesia. In non-obstetric population, although, NE infusion effectively maintained patients hemodynamics during general anesthesia, its use during spinal anesthesia was not adequately evaluated in elderly population

Conditions

Spinal Induced Hypotension; Elderly

Outcome Measures

Primary Outcomes (1)

• mean heart rate

  beat per minute

  for 45 minutes starting 2 minutes after induction of spinal anesthesia

Secondary Outcomes (3)

• incidence of bradycardia

  for 45 minutes starting 2 minutes after induction of spinal anesthesia

• incidence of reactive hypertension

  for 45 minutes starting 2 minutes after induction of spinal anesthesia

• Incidence of spinal induced hypotension

  for 45 minutes starting 2 minutes after induction of spinal anesthesia

Study Arms (2)

norepinephrine group

ACTIVE COMPARATOR

patients will receive NE infusion at a starting of rate of 1 ml/min of 8 mcg/ml solution (prepared by diluting 4 mg NE in 500 ml normal)

Drug: Norepinephrine

phenylephrine

ACTIVE COMPARATOR

patients will receive PE infusion at a starting rate of 1 ml/min of 100 mcg/ml solution (prepared by diluting 10 mg of PE in 100 ml normal saline)

Drug: phenylephrine

Interventions

Norepinephrine DRUG

infusion will be started after induction of spinal anesthesia

norepinephrine group

phenylephrine DRUG

infusion will be started after induction of spinal anesthesia

phenylephrine

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Elderly patients (\>65), ASA I-II-III, scheduled for hip joint surgery under spinal anesthesia

You may not qualify if:

• Contraindication of spinal anesthesia (patient's refusal, infection at injection site, allergy, increased intracranial tension, coagulopathy, tight valvular lesion),
• history of allergy to any of the study's drugs,
• Patients with cardiac morbidities (impaired contractility with ejection fraction \< 50%, heart block, arrhythmias),
• hypertensive patients,
• patients on beta blockers,
• patient with hyperthyroidism
• patients on monoamine oxidase inhibitors (MAOI) will be excluded from the study.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alaini Hospital

Cairo, 11562, Egypt

Location

MeSH Terms

Interventions

Norepinephrine; Phenylephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 11, 2019
• Study Start: January 1, 2020
• Primary Completion: March 26, 2020
• Study Completion: March 26, 2020
• Last Updated: September 1, 2021

Record last verified: 2021-08

Locations

EG (1)