Effects of Sedation on Spinal Anesthesia-induced Maternal Hypotension

NCT02732197 | Completed

• 1 other identifier: 2015/4
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Background: This study was designed to investigate the effect of sedation on the occurrence of maternal hypotension in preoperatively anxious parturients undergoing urgent category-1 Cesarean section (C/S) under spinal anesthesia. Methods: After institutional ethics committee approval, prospectively collected data of 1824 parturients undergoing C/S were reviewed. Parturients with high preoperative anxiety scores (visual analogue scale for anxiety (VAS-A)≥70) undergoing C/S under spinal anesthesia with thiopental (Group S=49) and without any other type of sedation (Group NS=53) were included in the analysis. Hemodynamic parameters were documented and maximum systolic arterial pressure (SAP) reductions from the baseline after spinal anesthesia were calculated. Incidences of hypotension (SAP≥30% decrease from baseline or \<100 mmHg) and bradycardia (HR\<55 beats/min), and related-ephedrine and -atropine requirements were noted. Our primary endpoint was to compare the maximum SAP reductions from the baseline values in Groups S and NS. Secondary endpoints were incidences of hypotension and bradycardia, required ephedrine and atropine doses, newborn Apgar scores at 1st and 5th min.

Conditions

Cesarean Section; Preoperative Anxiety; Spinal Anesthesia; Sedation; Maternal Hypotension

Outcome Measures

Primary Outcomes (1)

• Maximum systolic arterial pressure (SAP) reductions from the baseline values

  % SAP reduction after spinal anesthesia

  0-10 minutes

Secondary Outcomes (8)

• Incidence of maternal hypotension

  0-30 minutes

• Incidence of maternal bradycardia

  0-30 minutes

• Ephedrine requirement

  0-30 minutes

• Atropine requirement

  0-30 minutes

• Incidence of maternal nausea

  0-30 minutes

Study Arms (2)

Sedation (S)

Parturients who received IV thiopental 2 mg kg-1 and if necessary additional 50 mg immediately after spinal anesthesia until reaching at least Ramsay sedation score of 3 (1: patient anxious, agitated or restless, 6: patient with no response to light glabella tap or loud auditory stimulus.).

Drug: Sedation

No sedation (NS)

Parturients who did not receive any sedative agent after the spinal anesthesia performance.

Drug: No sedation

Interventions

Sedation DRUG

Parturients who received IV thiopental 2 mg kg-1 and if necessary additional 50 mg immediately after spinal anesthesia until reaching at least Ramsay sedation score of 3 (1: patient anxious, agitated or restless, 6: patient with no response to light glabella tap or loud auditory stimulus.).

Also known as: Thiopental

Sedation (S)

No sedation DRUG

Parturients did not receive any type of sedation after spinal anesthesia.

Also known as: No drug

No sedation (NS)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Parturients undergoing urgent category-1 Cesarean section (C/S) under spinal anesthesia

You may qualify if:

• Urgent category-1 C/S
• ASA physical status I-II
• Aged between 18 and 35 years
• Term (≥37 weeks) singleton pregnancy
• BMI \<40 kg/m2
• Height \>150 cm or \<180 cm
• High preoperative anxiety scores (visual analogue scale for anxiety (VAS-A) ≥70)
• Spinal anesthesia with thiopental sodium sedation
• Spinal anesthesia without any sedation

You may not qualify if:

• Preoperative prehydration
• Placenta previa
• Placenta accreta
• Hypertension
• Pregnancy-induced hypertension
• Urgent category ≥2
• General anesthesia
• Spinal anesthesia with sedation other than thiopental sodium

Sponsors & Collaborators

• Van Training and Research Hospital: lead

Study Sites (1)

Van Training and Research Hospital, Department of Anesthesiology

Van, Turkey (Türkiye)

Location

Related Publications (1)

• Orbach-Zinger S, Ginosar Y, Elliston J, Fadon C, Abu-Lil M, Raz A, Goshen-Gottstein Y, Eidelman LA. Influence of preoperative anxiety on hypotension after spinal anaesthesia in women undergoing Caesarean delivery. Br J Anaesth. 2012 Dec;109(6):943-9. doi: 10.1093/bja/aes313. Epub 2012 Sep 10.

  PMID: 22964265 RESULT

MeSH Terms

Interventions

Thiopental

Intervention Hierarchy (Ancestors)

Thiobarbiturates; Barbiturates; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Cenk Sahan, MD

  Design and conduct the study, review and analyze the data, and write the manuscript

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Anesthesiologist

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 8, 2016
• Study Start: August 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: April 11, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)