Analysis of Cisatracurium Consumption in Balanced Anesthesia With 1% Sevoflurane, and With Only Sevoflurane, Using a Closed-loop Computer Controlled System Infusion.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joomye Shehzaad, Tianjin Medical University General Hospital
ClinicalTrials.gov Identifier:
NCT01736371
First received: November 25, 2012
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

The aim in this study was to quantify the difference in cisatracurium and sufentanil consumption, and its recovery period, when patients are under balanced general anesthesia with 1% sevoflurane and patients under only sevoflurane general anesthesia, using a closed loop computer control infusion. Investigators further investigated this effect on its recovery period and sufentanyl consumption.


Condition Intervention
Drug Interaction Potentiation
Drug: 1% Sevoflurane
Drug: Propofol
Drug: Sevoflurane

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Analysis of Cisatracurium Consumption in Balanced Anesthesia With 1% Sevoflurane, and With Only Sevoflurane, Using a Closed-loop Computer Controlled System Infusion.

Resource links provided by NLM:


Further study details as provided by Tianjin Medical University General Hospital:

Primary Outcome Measures:
  • Cisatracurium consumption rate. [ Time Frame: At the time of surgery. ] [ Designated as safety issue: Yes ]
    Measurements were done intraoperatively. Investigators obtained data from the closed loop computer system, from which the intra-operative consumption of cisatracurium were obtained from each patient. Data were collected only during surgery. Each patient had different cisatracurium consumption rate, and the mean consumption rate of the patients within the same group were calculated, and compared with the means from the other groups.


Secondary Outcome Measures:
  • Analysis of Means of Recovery Index. [ Time Frame: 30 minutes post operative. ] [ Designated as safety issue: Yes ]
    Recovery Index was the time for the Train-Of-Four ratio (TOF) to increase from 25% to 75%. The TOF ratio was recorded every minute till it reached 90%. Time taken for each patient was from 5 to 25 minutes. Investigators compared the average recovery index of patients from each group.


Other Outcome Measures:
  • Sufentanil Consumption. [ Time Frame: At time of surgery ] [ Designated as safety issue: Yes ]
    Measurements were done intraoperatively, from which the intra-operative consumption of sufentanil were obtained from each patient. Data were collected only during surgery. Investigators compared the average sufentanil consumption between between groups.


Enrollment: 156
Study Start Date: January 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Total Intravenous Anesthesia
Only propofol infusion is used for maintenance of anesthesia keeping Bispectral Index (BIS) between 45-55.
Drug: Propofol
In this group the maintenance of anesthesia is maintained by only propofol infusion.
Other Name: Total Intravenous Anesthesia
Active Comparator: 1% Sevoflurane
1% Sevoflurane with propofol infusion is used for maintenance. BIS is kept between 45-55 by adjusting propofol infusion.
Drug: 1% Sevoflurane
In this group of patients, the maintenance of anesthesia is done by 1% sevoflurane + propofol infusion. Propofol infusion is adjusted according to the Bispectral Index.
Active Comparator: Sevoflurane
Only Sevoflurane is used for maintenance keeping BIS between 45-55
Drug: Sevoflurane
In this group only sevoflurane was used for maintenance of anesthesia. the dose of sevoflurane is adjusted to maintain Bispectral Index within 45 and 55.
Other Name: Sevoflurane

Detailed Description:

156 patients of American Society of Anesthesiologists (ASA) physical status I and II were assigned to three groups. The patients were all on schedule for elective general surgery under general anesthesia with duration of at two to four hours. All patients were induced with Etomidate (0.2mg/kg), Midazolam (0.05-0.1mg/kg), Sufentanil (0.3-0.5µg/kg) and a bolus dose of Cisatracurium (0.15mg/kg). Patients were aged between 20 and 65. The maintenance of anesthesia in each group varies as follows: Patients in Group 1 were all maintained with Total Intravenous Anesthesia, Group 2 with Sevoflurane at 1% and propofol infusion, Group 3 with only sevoflurane. Muscle paralysis is maintained using a closed-loop computer gated infusion of Cisatracurium which kept T1 <1% by giving increasing the infusion rate intra-operatively when required. Analgesia was maintained by intermittent bolus dose of 10-20 µg of Sufentanil.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients aged 20 and 65.
  • Patients with ASA 1 and 2.
  • Patients for elective abdominal general surgery

Exclusion Criteria:

  • Patients with the following diseases are excluded, since they are known to cause generalized neuromuscular weakness:

Neuromuscular junction disorders (e.g.. myasthenia gravis) Myopathies (e.g.. Muscular Dystrophies, Rhabdomyolysis) Peripheral Neuropathies (e.g. Guillain-Barre Syndrome, Polyneuropathies) Encephalopathies (Septic and Toxic-metabolic Encephalopathy) Patients with renal and liver diseases.

  • Patients who are sent intubated to ICU after surgery.
  • Patients refusal
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01736371

Locations
China
Tianjin Medical University
Tianjin, China, 300070
Sponsors and Collaborators
Tianjin Medical University General Hospital
Investigators
Principal Investigator: Shehzaad Joomye, M.D. Tianjin Medical University General Hospital
  More Information

No publications provided

Responsible Party: Joomye Shehzaad, Joomye Shehzaad M.D., Tianjin Medical University General Hospital
ClinicalTrials.gov Identifier: NCT01736371     History of Changes
Other Study ID Numbers: Cis-sevo-123
Study First Received: November 25, 2012
Last Updated: November 28, 2012
Health Authority: China: Ethics Committee

Keywords provided by Tianjin Medical University General Hospital:
Sevoflurane
Cisatracurium infusion consumption
Closed loop computer control system
Recovery Index

Additional relevant MeSH terms:
Anesthetics
Propofol
Sevoflurane
Cisatracurium
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 19, 2014