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

Primary Purpose

Cesarean Section, Hypotension, Spinal Anaesthesia

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
sitting position
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cesarean Section

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

sitting position

supine position

Arm Description

patients will be left in the sitting position

patients will lie down immediately after injection

Outcomes

Primary Outcome Measures

average systolic blood pressure
mmHg

Secondary Outcome Measures

post-spinal anaesthesia hypotension
frequency of patients with decreased systolic blood pressure less than 80% of the baseline reading
severe post-spinal anaesthesia hypotension
frequency of patients with decreased systolic blood pressure less than 60% of the baseline reading
reactive hypertension
percentage of patients with increased systolic blood pressure more than 120% of the baseline reading
nausea and vomiting
frequency
norepinephrine requirement
mcg
ephedrine requirement
mg
atropine requirement
mg
umbilical cord blood gases
pH
Apgar score
assessing the appearance, pulse, grimace, activity, respiration on a scale from zero to two, then summing up the five values thus obtained. The resulting score ranges from zero to 10.

Full Information

First Posted
February 25, 2021
Last Updated
February 27, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04777123
Brief Title
Prevention of Post-spinal Anesthesia Hypotension in Caesarean Delivery Using Delayed Supine Positioning
Official Title
Prevention of Post-spinal Anesthesia Hypotension in Caesarean Delivery Using Delayed Supine Positioning: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Upon arrival to operating room, Monitors will be applied (electrocardiography - pulse oximetry - non-invasive blood pressure monitor). All measurements will be taken before IV line insertion and premedications. Baseline systolic blood pressure will be obtained in the supine position as the mean of three consecutive readings at 2-minute intervals with a difference of less than 10%. After insertion of a peripheral 18-gauge line with a three way valve for fluids and vasopressor infusion; Premedication's with ranitidine (50mg) and ondansetron (4 mg) will be administered. Subarachnoid block (SAB) will be done in sitting position under complete asepsis in L3-L4 or L4-L5 interspace using 25 g spinal needle. 11 mg of 0.5% intrathecal hyperbaric Bupivacaine and 25um fentanyl will be administered. Block success will be assessed using pinprick or sensation to cold besides adequate motor block. Patients with failed SAB (Defined as sensory level below T4) will be excluded as well as patients with high spinal block (defined as spinal anaesthesia in which spinal denervation extends to second or third thoracic dermatome or sometimes up to cervical dermatomes). Co-hydration will be continued up to a maximum of 1.5 litres (patients with intraoperative blood loss over 1000 ml will be excluded from the study). After delivery of the foetus, oxytocin will be given as an initial bolus of 0.5 IU over five seconds followed by 40 mIU/minute infusion. Inspired air will be supplemented with oxygen 3 l/min via a nasal catheter until delivery. Continuous norepinephrine fixed rate infusion will be given to both groups as 5 mcg norepinephrine bolus at the same time cerebrospinal fluid obtained followed by norepinephrine infusion in a starting dose of 0.05 mcg/Kg/min. Norepinephrine will be prepared as 8 mcg/mL and will be delivered using a syringe pump. Post-spinal hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection to delivery of the foetus) will be managed by IV ephedrine 9 mg. Severe post-spinal hypotension (defined as decreased SBP less than 60% of the baseline reading) will be managed by IV ephedrine 15 mg. Additional vasopressor bolus was given if SBP did not respond to the first dose within 2 minutes. Intraoperative hypertension (defined as SBP >120% of the baseline reading) will be managed by stopping norepinephrine infusion. The infusion will be resumed when blood pressure returned to its normal value. Intraoperative bradycardia (defined as heart rate less than 55 bpm without hypotension during the period from intrathecal injection to delivery of the fetus) will be managed by stopping the vasopressor infusion. If bradycardia was associated with hypotension, the patient was managed by IV ephedrine 9 mg. If bradycardia persisted after the previous measures, an IV atropine bolus (0.5 mg) will be given. Norepinephrine total dose will be calculated in both groups for comparison purposes. Measurements will be taken every 2 minutes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section, Hypotension, Spinal Anaesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sitting position
Arm Type
Active Comparator
Arm Description
patients will be left in the sitting position
Arm Title
supine position
Arm Type
No Intervention
Arm Description
patients will lie down immediately after injection
Intervention Type
Other
Intervention Name(s)
sitting position
Intervention Description
patients will be left seated for 2 minutes after subarachnoid injection
Primary Outcome Measure Information:
Title
average systolic blood pressure
Description
mmHg
Time Frame
immediately after SAB till delivery of fetus
Secondary Outcome Measure Information:
Title
post-spinal anaesthesia hypotension
Description
frequency of patients with decreased systolic blood pressure less than 80% of the baseline reading
Time Frame
immediately after SAB till delivery of fetus
Title
severe post-spinal anaesthesia hypotension
Description
frequency of patients with decreased systolic blood pressure less than 60% of the baseline reading
Time Frame
immediately after SAB till delivery of fetus
Title
reactive hypertension
Description
percentage of patients with increased systolic blood pressure more than 120% of the baseline reading
Time Frame
immediately after SAB till delivery of fetus
Title
nausea and vomiting
Description
frequency
Time Frame
immediately after SAB till delivery of fetus
Title
norepinephrine requirement
Description
mcg
Time Frame
immediately after SAB till delivery of fetus
Title
ephedrine requirement
Description
mg
Time Frame
immediately after SAB till delivery of fetus
Title
atropine requirement
Description
mg
Time Frame
immediately after SAB till delivery of fetus
Title
umbilical cord blood gases
Description
pH
Time Frame
1 minutes after delivery
Title
Apgar score
Description
assessing the appearance, pulse, grimace, activity, respiration on a scale from zero to two, then summing up the five values thus obtained. The resulting score ranges from zero to 10.
Time Frame
at 1 minute and 5 minutes post-delivery.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Full term (above 37 weeks gestation). Singleton. Pregnant woman ASA II scheduled for elective caesarean section aged between 18 and 35 years. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maha Mostafa, M.D
Phone
01000365115
Email
maha.mostafa@cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Hasanin
Organizational Affiliation
Cairo University Kasr Alainy Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data are not publicly available. Data are available from the authors upon reasonable request and after permission of Cairo university

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

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