Dose-Response Relationship, Drug Clinical Trial
— LOCOfficial title:
The Effects of Spinal Anesthesia on ED50 and BIS50 of Etomidate for the Loss of Consciousness
Verified date | August 2017 |
Source | General Hospital of Ningxia Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 54 |
Est. completion date | July 15, 2017 |
Est. primary completion date | July 15, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | General Hospital of Ningxia Medical University | Yinchuan | Ningxia |
Lead Sponsor | Collaborator |
---|---|
General Hospital of Ningxia Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | The change of Mean Arterial Pressure (MAP) | Baseline, l min (T1), 2min (T2), 3min (T3), 5min (T5) after administration of etomidate | ||
Secondary | The change of heart rate (HR) | Baseline, l min (T1), 2min (T2), 3min (T3), 5min (T5) after administration of etomidate |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT02781246 -
Effect of Perineural Dexmedetomidine on the ED50 Ropivacaine for Brachial Plexus Blocks in Pediatric Patients: a Randomized Trial
|
Phase 4 | |
Completed |
NCT03568396 -
Validation of Pupillary Response to Nociceptive Stimulation in Cardiac Surgery During Extracorporeal Circulation Period
|
||
Recruiting |
NCT01219803 -
Trial of Different Dosages' Ge Gen Qin Lian Decoction in the Treatment of Type 2 Diabetes
|
N/A |