The Effects of Spinal Anesthesia on ED50 and BIS50 of Etomidate for the Loss of Consciousness

NCT03240055 | Completed DMC

• 1 other identifier: mz2017
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effect of spinal anesthesia on ED50 and BIS50 of etomidate for the loss of consciousness (LOC) by using up-and-down method.The hypothesis was that spinal anesthesia could significantly reduce the etomidate bolus dose for the LOC and could also achieve hemodynamic stability during anesthesia induction.

Conditions

Dose-Response Relationship, Drug

Keywords

spinal anesthesia; etomidate; median effective dose; BIS50

Outcome Measures

Primary Outcomes (2)

• Median effective dose (ED50)of etomidate at which 50% of patients lose consciousness

  We want to determine Median effective dose (ED50) of etomidate at which 50% of patients lose consciousness in the SE and E group, respectively. It is a value，like 0.105mg/kg. Patients were considered to be loss of consciousness if there Observer's Assessment of Alertness/Sedation (OAA/S) scores were 2,1,or 0.

  After etomidate administration to the lowest BIS value appears，usually about 4 minutes

• BIS value (BIS50) of etomidate at which 50% of patients lose consciousness

  We want to determine BIS value (BIS50) of etomidate at which 50% of patients lose consciousness in the SE and E group, respectively. It is a unitless value，like 60. Patients were considered to be loss of consciousness if there Observer's Assessment of Alertness/Sedation (OAA/S) scores were 2,1,or 0.

  After etomidate administration to the lowest BIS value appears，usually about 4 minutes

Secondary Outcomes (2)

• The change of Mean Arterial Pressure (MAP)

  Baseline, l min (T1), 2min (T2), 3min (T3), 5min (T5) after administration of etomidate

• The change of heart rate (HR)

  Baseline, l min (T1), 2min (T2), 3min (T3), 5min (T5) after administration of etomidate

Study Arms (2)

Group SE

EXPERIMENTAL

21 patients received spinal anesthesia first. After confirmation of the level (T4-T6) of the sensory anesthesia, the sequential administration of etomidate was conducted

Drug: spinal anesthesia

Group E

PLACEBO COMPARATOR

27 patients without spinal anesthesia in this group received sequential administration of etomidate

Other: etomidate

Interventions

spinal anesthesia DRUG

The spinal puncture was performed with a 25 G Sprotte needle at the L3-4 or L2-3 interspinous space. Hyperbaric bupivacaine 0.5% (3 ml) was administered into the spinal space. Hyperbaric bupivacaine is obtained through the addition of glucose 10% (1ml) to bupivacaine 0.75% (2ml). Cerebrospinal fluid aspiration (0.1 ml) was done to confirm correct needle placement before and after spinal drug administration. Whereafter the patient was turned rapidly to the supine position, sensory anesthesia height was evaluated bilaterally using a pinprick test with the sharp tip of a safety pin every 1 min until 15 min after the initiation of the spinal anesthesia, bed tilting (upwards, horizontal, or downwards) was performed until bilateral sensory anesthesia level was confirmed to remain at the T4-T6 level

Group SE

etomidate OTHER

receive etomidate only

Group E

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I-II
• Body mass index (BMI) between 18.0 and 24.5 kg/m2
• Undergoing short elective laparotomy procedures, hysteroscopic and vaginal operation

You may not qualify if:

• Contraindication to spinal anesthesia
• Hearing loss
• History of cardiovascular disease, psychiatric and central nervous system diseases
• Hepatic or renal dysfunction
• Severe diabetes or hyperkalemia
• History of drug and alcohol abuse
• An allergy to amide local anesthetics or etomidate
• Adrenocortical hypofunction

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

MeSH Terms

Interventions

Anesthesia, Spinal; Etomidate

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Li Ningkang

  General Hospital of Ningxia Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: August 4, 2017
• Study Start: June 1, 2017
• Primary Completion: July 15, 2017
• Study Completion: July 15, 2017
• Last Updated: September 6, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)