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The Effects of Keeping the Patient in a Sitting Position for One Minute After Spinal Anesthesia

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ClinicalTrials.gov Identifier: NCT03834259
Recruitment Status : Completed
First Posted : February 7, 2019
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Gulsah Karaoren, Umraniye Education and Research Hospital

Brief Summary:
The aim of this study was to examine the effect of keeping the patient in a sitting position for 1 minute after spinal anaesthesia in elective caesarean operations, primarily on the formation of hypotension and secondarily on nausea-vomiting, the need for ephedrine and the block characteristics.

Condition or disease Intervention/treatment Phase
Hypotension Spinal Anaesthesia Procedure: sitting position Procedure: supine position Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effects of Keeping the Patient in a Sitting Position for One Minute After Spinal Anesthesia on Hypotension, Nausea-vomiting and Ephedrine Consumption
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ephedrine

Arm Intervention/treatment
Active Comparator: Group 1
12.5 mg 0.5% hyperbaric bupivacaine
Procedure: sitting position
keeping the patient in a sitting position after spinal anaesthesia

Active Comparator: Group 2
10 mg 0.5% hyperbaric bupivacaine
Procedure: supine position
keeping the patient in supine position after spinal anaesthesia

Active Comparator: Group 3
12.5 mg 0.5% hyperbaric bupivacaine
Procedure: supine position
keeping the patient in supine position after spinal anaesthesia




Primary Outcome Measures :
  1. systolic arterial hypotension [ Time Frame: every 3 minutes until the delivery and every 5 minutes until the end of surgery ]
    reduction of >25% in the basal systolic arterial pressure


Secondary Outcome Measures :
  1. sensory block [ Time Frame: 10 minutes after spinal block ]
    assesment of the time to reach T12 level with pin prick test

  2. ephedrine requirement time [ Time Frame: 1 hour after spinal block ]
    the time to first administration of ephedrine as minutes after spinal block

  3. amount of ephedrine [ Time Frame: 1 hour after spinal block ]
    administrated total ephedrine dosage as mg during surgery

  4. surgeon and patient satisfaction [ Time Frame: 24 hours after spinal block ]
    1= poor, 2=fair, 3= good, 4= very good

  5. motor block [ Time Frame: 24 hours after spinal block ]
    time to Bromage Score 0 after applying spinal block



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   the study was designed in caesarean section operations
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • aged 18 - 45 years,
  • ASA physical status
  • I - II,
  • BMI of 25-30
  • who were undergoing elective CS

Exclusion Criteria:

  • vertebral anomaly,
  • peripheral vascular disease,
  • cardiovascular or psychiatric disorder,
  • severe anemia,
  • coagulopathy
  • infection in the intervention region

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Responsible Party: Gulsah Karaoren, associate professor, Umraniye Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03834259     History of Changes
Other Study ID Numbers: GK12
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gulsah Karaoren, Umraniye Education and Research Hospital:
spinal anaesthesia
ephedrine

Additional relevant MeSH terms:
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Ephedrine
Hypotension
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Stimulants
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action