Dose-Response Relationship, DrugLOCNCT03240055
The Effects of Spinal Anesthesia on ED50 and BIS50 of Etomidate for the Loss of Consciousness
A study testing spinal anesthesia and etomidate in people with Dose-Response Relationship, Drug, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Dose-Response Relationship, Drug
- What is being tested?
- spinal anesthesia and etomidate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 15 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
About this study
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.
Read the 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
- Conditions
- Dose-Response Relationship, Drug
- Being tested
- spinal anesthesia, etomidate
- Keywords
- spinal anesthesia, etomidate, median effective dose, BIS50
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesiaDrug
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
etomidateOther
receive etomidate only
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: spinal anesthesia |
| Group E | Placebo comparator | 27 patients without spinal anesthesia in this group received sequential administration of etomidate Receives: Other: etomidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After etomidate administration to the lowest BIS value appears，usually about 4 minutes
Secondary outcomes (2)
The change of Mean Arterial Pressure (MAP)
Measured: Baseline, l min (T1), 2min (T2), 3min (T3), 5min (T5) after administration of etomidate
The change of heart rate (HR)
Measured: Baseline, l min (T1), 2min (T2), 3min (T3), 5min (T5) after administration of etomidate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start1 Jun 2017
- Primary completion15 Jul 2017
- Study completion15 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dose-Response Relationship, DrugStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Ningkang, Principal investigator, General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240055
- Sponsor's protocol ID
- mz2017
- Acronym
- LOC
- Status last verified
- Aug 2017
- First submitted
- 21 Jul 2017
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: safety
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Spinal Anesthesia on ED50 and BIS50 of Etomidate for the Loss of Consciousness
- ClinicalTrials.gov ID
- NCT03240055
- Acronym / sponsor ID
- LOC / mz2017
- Conditions
- Dose-Response Relationship, Drug
- Keywords
- spinal anesthesia, etomidate, median effective dose, BIS50
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 15 Jul 2017 (actual)
- Study completion
- 15 Jul 2017 (actual)
- First posted
- 4 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group SE | Experimental | Drug: spinal anesthesia21 patients received spinal anesthesia first. After confirmation of the level (T4-T6) of the sensory anesthesia, the sequential administration of etomidate was conducted |
| Group E | Placebo comparator | Other: etomidate27 patients without spinal anesthesia in this group received sequential administration of etomidate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Contraindication to spinal anesthesia
- Hearing loss
- History of cardiovascular disease, psychiatric and central nervous system diseases
- Hepatic or renal dysfunction
- Severe diabetes or hyperkalemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal anesthesiaThe 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 | Drug | Group SE |
| etomidatereceive etomidate only | Other | Group E |
Primary outcome
Median effective dose (ED50)of etomidate at which 50% of patients lose consciousness
Time frame: After etomidate administration to the lowest BIS value appears，usually about 4 minutes
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
Time frame: After etomidate administration to the lowest BIS value appears，usually about 4 minutes
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.
2 secondary outcomes
The change of Mean Arterial Pressure (MAP)
Time frame: Baseline, l min (T1), 2min (T2), 3min (T3), 5min (T5) after administration of etomidate
The change of heart rate (HR)
Time frame: Baseline, l min (T1), 2min (T2), 3min (T3), 5min (T5) after administration of etomidate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Individual participant dataSharing planned: No. safety
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Ningkang principal investigator
General Hospital of Ningxia Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal anesthesia and etomidate in people with Dose-Response Relationship, Drug, run by General Hospital of Ningxia Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median effective dose (ED50)of etomidate at which 50% of patients lose consciousness (time frame: After etomidate administration to the lowest BIS value appears，usually about 4 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.