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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01282203
Other study ID # P12-638
Secondary ID
Status Completed
Phase N/A
First received January 21, 2011
Last updated January 28, 2013
Start date July 2011
Est. completion date November 2011

Study information

Verified date January 2013
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority Kazakhstan: National Center for Expertise of Drugs, Medical Products and EquipmentKazakhstan: Ministry of Public Health
Study type Observational

Clinical Trial Summary

The main objective of this post-marketing observational study is to collect data from the use of general anesthesia in patients undergoing any surgery to create local recommendations. These data will be based on the evaluation of volatile induction and maintenance anesthesia (VIMA) with Sevorane® (sevoflurane) in adult patients requiring general anesthesia for surgery in terms of quality of anesthesia and its influence on cardiovascular system in common clinical practice in Kazakhstan.


Description:

This post-marketing observational study will be conducted in a prospective, multi-centre format. It is a non-interventional, observational study in which Sevorane is prescribed for adult patients undergoing general surgery for induction and maintenance of anesthesia in the usual manner in accordance with the terms of the local marketing authorization. Sevorane is used for induction and maintenance anesthesia by the choice of anesthesiologist. No additional procedures (other than standard of care) shall be applied to the patients. Each patient will be observed from the start of anesthesia through anesthesia end. Markers of myocardial ischemia will be detected up to the first 24 hours after anesthesia (if available). Additionally the correlation between the experience and training background of anesthesiologists and patient related outcomes of general anesthesia with Sevorane as a single anesthetic will be assessed.


Recruitment information / eligibility

Status Completed
Enrollment 1122
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients needing general anesthesia for planned or urgent surgery for whom Sevorane is used for induction and maintenance anesthesia by the choice of anesthesiologist

- Age greater than or equal to 18 years

Exclusion Criteria:

- Known sensitivity to sevoflurane or other anesthetic containing halogen

- Known or suspected genetic susceptibility to malignant hyperthermia

- Receiving regional anesthetic techniques

- Receiving intravenous anesthesia

- A history of unexplained moderate/severe hepatic dysfunction with jaundice, fever, and/or eosinophilia in association with halogenated anesthetics

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Kazakhstan Site Reference ID/Investigator# 51851 Almaty
Kazakhstan Site Reference ID/Investigator# 54703 Almaty
Kazakhstan Site Reference ID/Investigator# 51843 Astana
Kazakhstan Site Reference ID/Investigator# 51844 Astana
Kazakhstan Site Reference ID/Investigator# 54705 Astana
Kazakhstan Site Reference ID/Investigator# 51842 Kokshetau
Kazakhstan Site Reference ID/Investigator# 51847 Kostanay
Kazakhstan Site Reference ID/Investigator# 64462 Kyzylorda
Kazakhstan Site Reference ID/Investigator# 51845 Semey
Kazakhstan Site Reference ID/Investigator# 51848 Shymkent
Kazakhstan Site Reference ID/Investigator# 54704 Uralsk
Kazakhstan Site Reference ID/Investigator# 44446 Zhezkazgan

Sponsors (1)

Lead Sponsor Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to Loss of Consciousness of Patients Administered Anesthesia Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (loss of eyelash reflex) occurred. Up to 10 minutes No
Primary Time to Awakening of Patients Measured from the time anesthesia administration was stopped until the patient responded to a verbal command. Every minute after anesthesia was stopped until the patient responded to a verbal command. No
Primary Time to Extubation of Patients Time to extubation was measured from the time anesthesia administration was stopped until tracheal extubation occurred. Every minute after anesthesia was stopped until extubation occurred No
Primary Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia The overall satisfaction of the anesthesiologist with the inhalation anesthesia with Sevorane for each patient was assessed by means of a numerical rating scale ranging from 0 (dissatisfied) to 10 (very satisfied). Day 1 No
Primary Patients' Overall Impression of Anesthesia With Sevorane After awakening from anesthesia, patients were surveyed regarding their overall impression of anesthesia with Sevorane. Patients selected one of the following answers: Excellent, positive, indifferent, or other. Day 1 No
Secondary Systolic Blood Pressure The systolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded. Before starting anesthesia to one hour after the surgery No
Secondary Diastolic Blood Pressure The diastolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded. Before starting anesthesia to one hour after the surgery No
Secondary Mean Arterial Pressure The mean arterial pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded. Before starting anesthesia to one hour after the surgery No
Secondary Heart Rate The heart rate of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded. Before starting anesthesia to one hour after the surgery No
Secondary Presence of Deviations in Electrocardiogram Assessments During Anesthesia Electrocardiogram (ECG) assessments performed during induction of the anesthesia and maintenance were analyzed with respect to the presence of the following deviations: Blockades (problems with heart electrical activity), extrasystoles (extra abnormal heart beats), arrhythmia (abnormal heart rate or rhythm), and myocardial ischemia (decreased blood flow to the heart). During induction and maintenance of anesthesia No
Secondary Cardiac Troponin (if Available) Troponin T values measured within 24 hours of anesthesia were to be collected when available. Within 24 hours after anesthesia No
Secondary Creatine Kinase Myocardial Isoenzyme (if Available) Creatine kinase myocardial isoenzyme values measured within 24 hours of anesthesia were to be collected when available. Within 24 hours after anesthesia No
Secondary Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia The anesthesiologists' length of clinical experience with Sevorane was collected (see Outcome Measure 15). The influence of this experience on the changes in hemodynamic parameters during anesthesia with Sevorane was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience with Sevorane and the changes in blood pressure, mean arterial pressure, and heart rate between T0 (before anesthesia) and T1 (at the end of induction), T2 (at the end of surgical incision), T3 (at the end of extubation), T4 ( 1 hour after the surgery), and the minimum and maximum values, respectively. Before starting anesthesia to one hour after the surgery No
Secondary Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening Anesthesiologists' length of clinical experience with general anesthesia and modern inhalation agents was collected (see Outcome Measure 15). The influence of this clinical experience on anesthesia parameters was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience with inhalation anesthesia and Sevorane on the time to extubation and the time to awakening, respectively. Every minute after anesthesia was stopped until the patient was extubated and until the patient responded to a verbal command No
Secondary Anesthesiologists' Duration of Clinical Experience With Anesthesia Mean number of years of participating anesthesiologists' clinical experience with general anesthesia, with modern inhalation agents, and with Sevorane. (See Outcome Measures 13 and 14 for correlated data.) Baseline No
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