Prevention of Post-spinal Anesthesia Hypotension in Caesarean Delivery Using Delayed Supine Positioning

NCT04777123 | Unknown

• 1 other identifier: MD-85-2019
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Maternal hypotension is a common complication after spinal anaesthesia for caesarean delivery. Prophylaxis against post-spinal hypotension (PSH) during caesarean delivery would prevent serious maternal and fetal complications. Various methods had been investigated for prophylaxis against maternal hypotension. The basic components of management of PSH are: 1. Fluid loading. 2. Pharmacological agents. 3. Positioning protocols. Although Fluid loading is superior to non-loading protocols during caesarean delivery, the incidence of Post-spinal hypotension is high with all fluid loading protocols. Thus; the value of fluid loading in caesarean delivery could not be used solely for prevention of PSH. Using vasopressors for prophylaxis against PSH is nearly fundamental during caesarean delivery. However, vasopressors are not devoid of side effects such as reflex bradycardia after phenylephrine and fetal acidosis after ephedrine. Thus, combining vasopressor prophylaxis and non-pharmacological protocols would help to decrease the dose of vasopressors, and consequently decreasing their side effects. Ondansetron had been also reported as a useful prophylactic drug from PSH with minimal side effects. Positioning protocols, such as operating table tilting or flexing, the use of wedges or mechanical displacers, leg wrapping or sequential compression devices, head down and head up positioning aim to reversing aortocaval compression and/or increasing venous return. The sitting position for a short period after spinal block in order to slow the onset of the spinal block. Keeping the patient in the sitting position after spinal block would also prevent extension of local anaesthetic solution to upper thoracic dermatomes which is an important factor in preventing maternal hypotension. no previous reports had evaluated the impact of sitting position within the context of a multimodal protocol for prophylaxis against maternal hypotension. In this study, we aim to evaluate the impact of 2-minute sitting position after spinal anesthesia on maternal hemodynamics when combined with prophylactic norepinephrine infusion plus preoperative bolus of ondansetron. We aim to reach the best possible maternal hemodynamic profile in addition to maintenance of adequate block level.

Conditions

Cesarean Section; Hypotension; Spinal Anaesthesia

Outcome Measures

Primary Outcomes (1)

• average systolic blood pressure

  mmHg

  immediately after SAB till delivery of fetus

Secondary Outcomes (9)

• post-spinal anaesthesia hypotension

  immediately after SAB till delivery of fetus

• severe post-spinal anaesthesia hypotension

  immediately after SAB till delivery of fetus

• reactive hypertension

  immediately after SAB till delivery of fetus

• nausea and vomiting

  immediately after SAB till delivery of fetus

• norepinephrine requirement

  immediately after SAB till delivery of fetus

Study Arms (2)

sitting position

ACTIVE COMPARATOR

patients will be left in the sitting position

Other: sitting position

supine position

NO INTERVENTION

patients will lie down immediately after injection

Interventions

sitting position OTHER

patients will be left seated for 2 minutes after subarachnoid injection

sitting position

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Full term (above 37 weeks gestation).
• Singleton.
• Pregnant woman ASA II scheduled for elective caesarean section aged between 18 and 35 years.

You may not qualify if:

• Contraindications to spinal anaesthesia.
• Obese patients (body mass index \>35).
• Peripartum bleeding.
• Impaired cardiac contractility (Ejection fraction\<45%).
• Cardiac arrhythmias (I.e. any rhythm other than normal sinus rhythm and sinus tachycardia).
• Valvular heart lesions (I.e. moderate to severe valve lesions).
• Pre-existing hypertension, pregnancy induced hypertensive disorders.
• Fetal abnormalities.
• Intraoperative blood loss over 1000 ml and failed/ high subarachnoid block.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Hypotension

Interventions

Sitting Position

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ahmed Hasanin

  Cairo University Kasr Alainy Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maha Mostafa, M.D

CONTACT

01000365115; maha.mostafa@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 2, 2021
• Study Start: March 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: March 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)