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

Primary Purpose

Dose-Response Relationship, Drug

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
spinal anesthesia
etomidate
Sponsored by
General Hospital of Ningxia Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dose-Response Relationship, Drug focused on measuring spinal anesthesia, etomidate, median effective dose, BIS50

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • General Hospital of Ningxia Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group SE

Group E

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

The change of Mean Arterial Pressure (MAP)
The change of heart rate (HR)

Full Information

First Posted
July 21, 2017
Last Updated
September 2, 2017
Sponsor
General Hospital of Ningxia Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03240055
Brief Title
The Effects of Spinal Anesthesia on ED50 and BIS50 of Etomidate for the Loss of Consciousness
Acronym
LOC
Official Title
The Effects of Spinal Anesthesia on ED50 and BIS50 of Etomidate for the Loss of Consciousness
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
July 15, 2017 (Actual)
Study Completion Date
July 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General Hospital of Ningxia Medical University

4. Oversight

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

5. Study Description

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.
Detailed Description
The combination of spinal with general anesthesia has been demonstrated to provide many clinically relevant advantages, however, this technique often experiences hypotension and bradycardia in the induction period of combined anesthesia. Etomidate is a carboxylated imidazole-derived hypnotic, and it is the most cardiovascularly stable intravenous induction drug, with the possible exception of ketamine. Meanwhile, the previous and our studies have been reported that spinal anesthesia has a direct sedative effect on animals and humans, and it markedly reduces the dose of hypnotic agents. To date, there is no dose-ranging study on the effect of spinal anesthesia on dosage of etomidate for the loss of consciousness (LOC). In the present study, investigators aim to investigate the effect of spinal anesthesia on the median effective dose (ED50) and the BIS value (BIS50) of etomidate at which 50% of patients lose consciousness compared to etomidate alone by using up-and-down method. Patients were randomly allocated to one of two groups: only etomidate in group E (n=27) and spinal anesthesia combined with etomidate in group SE (n=21) using a randomization table. Patients in the SE group received spinal anesthesia first, and bilateral sensory anesthesia level was confirmed to remain at the T4-T6 level. After confirmation of the level of sensory anesthesia, the administration of etomidate was conducted. The etomidate (Nhwa Pharmaceutical, Jiangsu, China) starting dose of E group and SE group is 0.105 mg/kg and 0.089mg/kg, respectively. The dose of etomidate used for next patient was determined according to the response of the previously tested patient using the up-and-down method. If the patient lose consciousness, the dose of etomidate was reduced by one dose gradient for the next patient, and if didn't lose consciousness, the dose of etomidate was increased by one dose gradient (one dose gradient is r=1:0.85, that is, the ratio of high dose/low dose which are adjacent two doses). The testing of different dose levels of etomidate continued on consecutive randomised patients until a sample size of seven crossover points from "conscious" to "LOC" was reached

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dose-Response Relationship, Drug
Keywords
spinal anesthesia, etomidate, median effective dose, BIS50

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group SE
Arm Type
Experimental
Arm Description
21 patients received spinal anesthesia first. After confirmation of the level (T4-T6) of the sensory anesthesia, the sequential administration of etomidate was conducted
Arm Title
Group E
Arm Type
Placebo Comparator
Arm Description
27 patients without spinal anesthesia in this group received sequential administration of etomidate
Intervention Type
Drug
Intervention Name(s)
spinal anesthesia
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
etomidate
Intervention Description
receive etomidate only
Primary Outcome Measure Information:
Title
Median effective dose (ED50)of etomidate at which 50% of patients lose consciousness
Description
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.
Time Frame
After etomidate administration to the lowest BIS value appears,usually about 4 minutes
Title
BIS value (BIS50) of etomidate at which 50% of patients lose consciousness
Description
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.
Time Frame
After etomidate administration to the lowest BIS value appears,usually about 4 minutes
Secondary Outcome Measure Information:
Title
The change of Mean Arterial Pressure (MAP)
Time Frame
Baseline, l min (T1), 2min (T2), 3min (T3), 5min (T5) after administration of etomidate
Title
The change of heart rate (HR)
Time Frame
Baseline, l min (T1), 2min (T2), 3min (T3), 5min (T5) after administration of etomidate

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Ningkang
Organizational Affiliation
General Hospital of Ningxia Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
safety

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

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