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Study of Cisatracurium and Sufentanil Consumption Using a Closed Loop Computer Control Infusion System

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ClinicalTrials.gov Identifier: NCT01785446
Recruitment Status : Unknown
Verified February 2013 by Guolin Wang, MD, PhD, Professor, Tianjin Medical University General Hospital.
Recruitment status was:  Recruiting
First Posted : February 7, 2013
Last Update Posted : February 7, 2013
Sponsor:
Collaborators:
Shehzaad Joomye
Haiyun Wang
Donglai Yan
Information provided by (Responsible Party):
Guolin Wang, MD, PhD, Professor, Tianjin Medical University General Hospital

Brief Summary:

The purpose of this study is to:

  • determine the effect of dexmedetomidine on cisatracurium infusion requirements and sufentanil consumption.
  • analyze the cisatracurium infusion requirements and sufentanil consumption in different age groups.

Condition or disease Intervention/treatment Phase
The Intraoperative Effect of Dexmedetomidine on Cisatracurium Infusion Consumption and Its Recovery Index. Effect of Dexmedetomidine on Sufentanil Consumption. Quantitative Analysis of Cisatracurium Infusion Requirements, Sufentanil Consumption and Recovery Index in Different Age Groups. Drug: Effect of dexmedetomidine on cisatracurium and sufentanil consumption Drug: Consumption of cisatracurium and sufentanil in different age groups. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Effect of Dexmedetomidine on Cisatracurium Infusion and Sufentanil Consumption and Its Variations in Different Age Groups, Using a Closed Loop Computer Controlled System.
Study Start Date : November 2012
Estimated Primary Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: P 1

In this group patients were aged from 20 to 45. Propofol infusion was used to maintain Bispectral Index (BIS) between 45 and 55.

Intermittent doses of sufentanil 10-20 microgram were given intra-operatively on a required basis.

Drug: Consumption of cisatracurium and sufentanil in different age groups.
For this intervention, we compared the cisatracurium consumption, refractory index and sufentanil consumption between group P1, P2 and P3.

Active Comparator: P 2

In this group patients were aged from 46 to 65. Propofol infusion was used to maintain Bispectral Index (BIS) between 45 and 55.

Intermittent doses of sufentanil 10-20 microgram were given intra-operatively on a required basis.

Drug: Effect of dexmedetomidine on cisatracurium and sufentanil consumption
In this intervention we compared the cisatracurium consumption, recovery index and sufentanil consumption between P2 and D. The reason we are comparing patients in group D with P2 is that because they belong to the same age group.
Other Name: Dexmedetomidine

Drug: Consumption of cisatracurium and sufentanil in different age groups.
For this intervention, we compared the cisatracurium consumption, refractory index and sufentanil consumption between group P1, P2 and P3.

Active Comparator: P 3

In this group patients were aged from 66 to 85. Propofol infusion was used to maintain Bispectral Index (BIS) between 45 and 55.

Intermittent doses of sufentanil 10-20 microgram were given intra-operatively on a required basis.

Drug: Consumption of cisatracurium and sufentanil in different age groups.
For this intervention, we compared the cisatracurium consumption, refractory index and sufentanil consumption between group P1, P2 and P3.

Active Comparator: D

In this group patients were aged from 46to 65. Propofol infusion was used to maintain Bispectral Index (BIS) between 45 and 55.

Dexmedetomidine infusion is started at induction,a bolus dose of 0.5 µg/kg is given over the first hour which is followed by infusion of 0.4 µg/kg/hr.

Intermittent doses of sufentanil 10-20 microgram were given intra-operatively on a required basis.

Drug: Effect of dexmedetomidine on cisatracurium and sufentanil consumption
In this intervention we compared the cisatracurium consumption, recovery index and sufentanil consumption between P2 and D. The reason we are comparing patients in group D with P2 is that because they belong to the same age group.
Other Name: Dexmedetomidine




Primary Outcome Measures :
  1. Cisatracurium infusion consumption. [ Time Frame: At the time of surgery ]
    Measurements were done during the operation. Cisatracurium infusion was controlled a closed loop computer system. The degree of neuromuscular blockage was assessed every 20 seconds throughout the procedure using the train of four testing. It was done by counting the number and amplitude of twitches evoked after electrical stimulus and the rate of infusion maintained itself at the low rate of 0.20µg/kg/min as long as the T1 response is less than 1%. When the T1 > 1%, the rate of infusion would automatically increase to 5.0 µg/kg/min until T1 < 1%, after which the infusion rate would fall back to 0.20µg/kg/min. The controlled infusion described above administered small doses of cisatracurium intra-operatively to maintain a muscle relaxation of more than 99%. The system saved the time and amount of drug given throughout the operation, from which the consumption was calculated in µg/kg/min.


Secondary Outcome Measures :
  1. Sufentanil consumption. [ Time Frame: At the time of operation. ]
    Analgesia was maintained by intermittent bolus dose of 10-20 µg of Sufentanil when the pulse and blood pressure would increase by more than 20% of the baseline, and BIS in the required range, as this would indicate an increase perception of pain but adequate anaesthesia. Sufentanil consumption was calculated for each patient in µg/kg/hr and the length of the operation was determined as from induction to the time of skin closure.


Other Outcome Measures:
  1. Recovery Index [ Time Frame: 30 minutes post-operative. ]
    Recovery Index, time for the Train-Of-Four (TOF) value to increase from 25% to 75%, was measured in each patient who completed the study. Its measurements were recorded in minutes.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA status 1 and 2.
  • Consent approval written and oral.
  • Patients scheduled for elective abdominal surgery under general anesthesia.

Exclusion Criteria:

  • Patients with neuromuscular disorders.
  • Patients with history of stroke, flaccid paralysis or other neurological disorders.
  • Significant renal, hepatic or cardiac dysfunction.
  • Consent refusal.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785446


Contacts
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Contact: Shehzaad Joomye, M.D. 8613072283346 s_joomye@hotmail.com

Locations
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China, Tianjin
Tianjin Medical University General Hospital Recruiting
Tianjin, Tianjin, China, 300052
Principal Investigator: Guolin Wang, MD, PhD, Professor         
Principal Investigator: Shehzaad Joomye, MD         
Sub-Investigator: Haiyun Wang, MD, PhD         
Sub-Investigator: Donglai Yan, MD         
Sponsors and Collaborators
Tianjin Medical University General Hospital
Shehzaad Joomye
Haiyun Wang
Donglai Yan
Investigators
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Principal Investigator: Guolin Wang, MD, PhD, Professor Tianjin Medical University General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guolin Wang, MD, PhD, Professor, M.D. PhD. Professor, Tianjin Medical University General Hospital
ClinicalTrials.gov Identifier: NCT01785446     History of Changes
Other Study ID Numbers: Cis-123
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013
Keywords provided by Guolin Wang, MD, PhD, Professor, Tianjin Medical University General Hospital:
Dexmedetomidine
Cisatracurion infusion
Sufentanil
Recovery Index
Closed loop computer control system
Additional relevant MeSH terms:
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Sufentanil
Dexmedetomidine
Atracurium
Cisatracurium
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Neuromuscular Blocking Agents
Neuromuscular Agents
Neuromuscular Nondepolarizing Agents
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents