Remifentanil versus sufentanil regimen for intensive care unit (ICU) postoperative sedation after coronary artery bypass graft surgery: a prospective, randomised and double-blinded study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15105737

Enrollment

Registered

2008-08-08

Start date

2005-09-26

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative sedation of an elective coronary artery bypass graft surgery (CABG) Circulatory System Other and unspecified disorders of circulatory system

Interventions

After approval by our ethics committee and written consent obtained the day before surgery, forty patients scheduled for elective CABG with CBP were randomised, using a closed-envelope system, to rece

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Both males and females, age >18 years 2. Patients scheduled for elective CABG with cardiopulmonary bypass (CBP) 3. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. Simultaneous valve surgery or any other combined surgery 2. Poor preoperative cardiac function (ejection fraction <30%, severe congestive heart failure) 3. Liver or renal disorders 4. Chronic respiratory diseases 5. Alcohol or drugs abuse and neurological or psychiatric conditions that might impair pain evaluation Postoperative exclusion criteria: 6. Situations where the administration of the anaesthetic regimen was maintained after the fourth postoperative hour

Design outcomes

Secondary

Measure	Time frame
1. Duration of non-invasive ventilation (VNI) 2. Duration of patient's recovery from anaesthesia 3. Time to eligible and actual tracheal extubation	—

Primary

Measure	Time frame
We analysed the effects of these two anaesthetic regimens, used in order to maintain the same depth of anaesthesia, during the early postoperative period: 1. Haemodynamic effects: Standard monitoring was used and included a CCO/SvO2 pulmonary artery catheter (Edwards Lifesciences, USA) 2. The following haemodynamic parameters were recorded every 30 minutes from H0 to H4 (duration of the sedation), then hourly until H8 and finally every 2 hours for the next 16 hours: 2.1. Heart rate (HR) 2.2. Invasive mean arterial pressure (mean AP) 2.3. Central venous pressure (CVP) 2.4. Mean pulmonary arterial pressure (mean PAP) 2.5. Pulmonary capillary wedge pressure (PCWP) 2.6. Continuous cardiac output (CCO) 2.7. Cardiac index (CI) 2.8. Mixed venous oxygen saturation (SvO2) 3. Biochemical markers of myocardial damage including troponine I and CPK-MB were analysed before surgery, and repeated at H0, H3, H8, H16 and H30 4. Respiratory effects: Arterial blood gases evaluated respiratory state, every 4 hours from H0 to 24 hours after extubation 5. Pain management: Pain evaluation was assessed by VAS ranging from 0: no pain to 100: worst imaginable pain. Each evaluation was performed at rest and just after deep inspiration (stress test). Use of VAS score and PCA recording of piritramide requirements evaluated the efficacy of pain control.	—

Measure

Time frame

We analysed the effects of these two anaesthetic regimens, used in order to maintain the same depth of anaesthesia, during the early postoperative period: 1. Haemodynamic effects: Standard monitoring was used and included a CCO/SvO2 pulmonary artery catheter (Edwards Lifesciences, USA) 2. The following haemodynamic parameters were recorded every 30 minutes from H0 to H4 (duration of the sedation), then hourly until H8 and finally every 2 hours for the next 16 hours: 2.1. Heart rate (HR) 2.2. Invasive mean arterial pressure (mean AP) 2.3. Central venous pressure (CVP) 2.4. Mean pulmonary arterial pressure (mean PAP) 2.5. Pulmonary capillary wedge pressure (PCWP) 2.6. Continuous cardiac output (CCO) 2.7. Cardiac index (CI) 2.8. Mixed venous oxygen saturation (SvO2) 3. Biochemical markers of myocardial damage including troponine I and CPK-MB were analysed before surgery, and repeated at H0, H3, H8, H16 and H30 4. Respiratory effects: Arterial blood gases evaluated respiratory state, every 4 hours from H0 to 24 hours after extubation 5. Pain management: Pain evaluation was assessed by VAS ranging from 0: no pain to 100: worst imaginable pain. Each evaluation was performed at rest and just after deep inspiration (stress test). Use of VAS score and PCA recording of piritramide requirements evaluated the efficacy of pain control.

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Countries

Belgium

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026