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Trial registered on ANZCTR


Registration number
ACTRN12614000935639
Ethics application status
Approved
Date submitted
20/08/2014
Date registered
1/09/2014
Date last updated
17/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Clonidine-sufentanil versus remifentanil in endoscopic sinus surgery
Scientific title
In patients undergoing endoscopic sinus surgery, does clonidine and sufentanil compared to remifentanil provide better quality surgical field in term of bleeding.
Secondary ID [1] 285197 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quality of surgical field in term of bleeding in endoscopic sinus surgery 292806 0
Condition category
Condition code
Anaesthesiology 293100 293100 0 0
Anaesthetics
Surgery 293101 293101 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients are randomized in two group using minimization.

For both groups patients are positioned 15 degrees reverse trendelenburg.
The trachea is intubated. Mechanical ventilation parameters are set to Peep: 3cmH2O, Respiratory rate: 12, Tidal volume: 6-8ml/kg. These parameters are then adjusted for a target EtCO2 of 30-35mmHg


Cata group
Anesthesia induction:
1. Lidocaine 1mg/kg I.V. bolus
2. Sufentanil 0.15mcg/kg I.V. bolus
3. Intravenous Propofol titrated to loss of eye lid reflex
4. Rocuronium 0.3mg/kg I.V. bolus
5. Clonidine 2mcg/kg slow I.V. bolus (for 5 min)
Anesthesia Maintenance: sevoflurane 1 MAC (inhalation)

15 min from the start of surgery, the Fromme score is assessed, if it's higher than 4 and the mean arterial pressure (MAP) is greater than 65mmHg and the last sufentanil injection occurred more than 45min ago then a new bolus of sufentanil 0.15mcg/kg is injected I.V. If the last sufentanil injection occurred within the last 45 minutes then a new bolus of clonidine 1mcg/kg I.V. is slowly injected (for five minutes) to a maximum total clonidine dose of 3mcg/kg.

If, during the procedure, the surgeon complaints about bleeding and the MAP is greater than 65mmHg and the last sufentanil injection occurred more than 45min ago then a new bolus of sufentanil 0.15mcg/kg is injected I.V. If the last sufentanil injection occurred less than 45 min ago then a new bolus of clonidine 1mcg/kg I.V. is slowly injected (for five minutes) to a maximum total clonidine dose of 3mcg/kg

If,during the procedure, the patient’s MAP fall below 55mmHg then ephedrine is titrated intravenously by 3mg for a MAP greater than 55mmHg.

In all cases, if ephedrine fails to raise the MAP the patient should receive neosynephrine or norepinephrine and leave the study.
If the surgeon is unable to perform the procedure due to bleeding despite a well followed protocol, the patient leaves the study.
Intervention code [1] 290068 0
Treatment: Drugs
Comparator / control treatment
Remi group
Anesthesia induction:
1. Lidocaine 1mg/kg I.V. bolus
2. Remifentanil I.V. infusion 0.25mcg/kg/min until trachea intubation. After that, the infusion rate is lowered to 0.12mcg/kg/min
3. Propofol I.V. injection titrated to loss of eye lid reflex
4. Rocuronium 0.3mg/kg I.V. injection

Anesthesia maintenance: sevoflurane 1 MAC (inhalation)

15 min from the start of the procedure, the Fromme score is assessed. If it is higher than 4 and the mean arterial pressure (MAP) is greater than 65mmHg then the rate of remifentanil infusion rate is doubled until a maximum of 1mcg/kg/min.

If, during the procedure, the surgeon complaints about bleeding and MAP is greater than 65mmHg then the remifentanil infusion rate is doubled until a maximum of 1mcg/kg/min.

During the surgery, if the patient’s MAP fall below 55mmHg then ephedrine is titrated intravenously by 3mg for MAP greater than 55mmHg and the remifentanil infusion rate is halved.

In all cases, if ephedrine fails to raise the MAP the patient should receive neosynephrine or norepinephrine and leave the study.
If the surgeon is unable to perform the procedure due to bleeding despite a well followed protocol, the patient leaves the study.
Control group
Active

Outcomes
Primary outcome [1] 292969 0
Fromme score (0-5).
Timepoint [1] 292969 0
15 min after beginning and at the end of the surgery.
Secondary outcome [1] 310035 0
Heartrate (measured by ECG and pulse oximeter) and Blood pressure (measured by an automated oscillometric device)
Timepoint [1] 310035 0
Heartrate is monitored continuously during surgery and the recovery room stay. Blood pressure is taken every 3 minutes during the surgery and every 10 minutes in the recovery room.
Secondary outcome [2] 310036 0
Time to eyes opening.
Timepoint [2] 310036 0
At the end of the surgery.
Secondary outcome [3] 310037 0
Time spent in the recovery room.
Timepoint [3] 310037 0
When the patient leaves the recovery room.
Secondary outcome [4] 310038 0
Pain scores (VAS).
Timepoint [4] 310038 0
During the recovery room stay.
Secondary outcome [5] 310039 0
Occurrence of adverse events in recovery (hypotension, bradycardia, nausea and vomiting).
Timepoint [5] 310039 0
During the recovery stay.
Secondary outcome [6] 310162 0
Amount of Piritramide received by the patient (The source of this information is the institutional computerized prescription system).
Timepoint [6] 310162 0
When the patient leaves the recovery room.

Eligibility
Key inclusion criteria
Patients undergoing elective endoscopic sinus procedures with ASA score I to III.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiac disorders other than supraventricular tachycardia
Cerebrovascular disorder
Renal or hepatic disorder
Non treated arterial hypertension
Beta blocking agent therapy
Platelet inhibiting agent or anticoagulant therapy
Coagulopathy
Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible patients will be approached during the anesthesia preoperative visit, days before the surgery. The anesthesia consultant will obtain an informed consent. The treatment received for each patient will be determined on the day of the procedure by minimization (handled by Qminim, online minimization at http://qminim.sourceforge.net).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Minimisation
The factors used for stratification include age, sex, Mackay-Lund score, preoperative oral corticoid treatment, ASA score and surgeon.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The purpose of the trial is to detect a difference of 1 point on the Fromme’s scale. The preliminary data on 40 patients allowed to estimate Fromme scale as 2.4 +/- 1.1 (mean +/- SD).Using a two-tailed non parametric test, with an alpha risk of 0.05, a beta risk of 0.20 (or a power of 0.80), a minimal difference of 1 and a SD of Fromme scale of 1.3, the total number of patients necessary to perform the comparison is 58 (computation by G*Power 3 software).

Planned statistical analysis
comparison of numerical variables : Wilcoxon-Mann-Whitney test
comparison of categorical variables : chi-square or Fisher exact test when appropriate
comparison of ordinal variables : Cochran-Armitage test
correlation between numerical variables: Spearman rank correlation coefficient
multivariate analysis if appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6303 0
Belgium
State/province [1] 6303 0
Namur

Funding & Sponsors
Funding source category [1] 289814 0
Hospital
Name [1] 289814 0
CHU Dinant-Godinne
Address [1] 289814 0
1,avenue Gaston Therasse
5530 Yvoir
Country [1] 289814 0
Belgium
Primary sponsor type
Individual
Name
Laurent Bairy
Address
CHU Dinant-Godinne-Anesthesiology
1, avenue Gaston Therasse
5530 Yvoir
Belgium
Country
Belgium
Secondary sponsor category [1] 288506 0
None
Name [1] 288506 0
Address [1] 288506 0
Country [1] 288506 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291545 0
Comite d'ethique hospitalier
Ethics committee address [1] 291545 0
CHU Dinant-Godinne
1, avenue Gaston Therasse
5530 Yvoir
Ethics committee country [1] 291545 0
Belgium
Date submitted for ethics approval [1] 291545 0
08/11/2013
Approval date [1] 291545 0
17/03/2014
Ethics approval number [1] 291545 0
B039201318956

Summary
Brief summary
The purpose of this study is to determine whether the use of remifentanil or clonidine and sufentanil for anesthesia provides the best surgical conditions for endoscopic sinus surgery in term of bleeding.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50814 0
Dr Laurent Bairy
Address 50814 0
CHU Dinant-Godinne
Service d'anesthesie
1, avenue Gaston Therasse
5530 Yvoir
Country 50814 0
Belgium
Phone 50814 0
+3281422111
Fax 50814 0
+3281423920
Email 50814 0
Laurent.Bairy@uclouvain.be
Contact person for public queries
Name 50815 0
Dr Laurent Bairy
Address 50815 0
CHU Dinant-Godinne
Service d'anesthesie
1, avenue Gaston Therasse
5530 Yvoir
Country 50815 0
Belgium
Phone 50815 0
+3281422111
Fax 50815 0
+3281423920
Email 50815 0
Laurent.bairy@uclouvain.be
Contact person for scientific queries
Name 50816 0
Dr Laurent Bairy
Address 50816 0
CHU Dinant-Godinne
Service d'anesthesie
1, avenue Gaston Therasse
5530 Yvoir
Country 50816 0
Belgium
Phone 50816 0
+3281422111
Fax 50816 0
Email 50816 0
Laurent.Bairy@uclouvain.be

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary