Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001351303
Ethics application status
Approved
Date submitted
24/07/2017
Date registered
26/09/2017
Date last updated
22/01/2020
Date data sharing statement initially provided
22/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Propofol and remifentanil patient controlled sedation/analgesia versus remifentanil infusion during interventional radiological procedures.
Scientific title
Propofol and remifentanil patient controlled sedation/analgesia versus remifentanil infusion
for moderate sedation during interventional radiological procedure : a prospective randomized trial.
Secondary ID [1] 292439 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral angiography, 304051 0
Hepatic tumor ablation
 304269 0
Placing tunneled catheter
 304366 0
Percutaneous hepatic cyst drainage
 304367 0
Splenic artery chemoembolization
 304368 0
Percutaneous transhepatic biliary drainage
 304369 0
The renal artery chemoembolization 304370 0
Condition category
Condition code
Anaesthesiology 303374 303374 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study was conducted with the approval of Faculty Ethics Committee (Ref. no. 2009/357). This study included 60 patients between 18 and 70 years of age who had ASA I–III and were undergoing interventional radiology procedures for diagnostic and treatment purposes. Informed consent was obtained from all individual participants included in the study. Patients who had allergic reaction to medications to be used, patients with serious cardiovascular and respiratory system diseases, obesity, sleep apnea syndrome, high risk of pulmonary aspiration, or pregnancy, patients who were unable to grasp the meaning of PCAS, and unaccompanied patients were excluded from the study.
Patients who were scheduled to undergo painful interventional radiological procedures under local anesthesia were randomly assigned into either the remifentanil (Ultiva; GlaxoSmithKline, Italy) infusion group (Group R; (n) 30 patient) or the remifentanil–propofol (Propofol; Fresenius Kabi, Sweden) PCAS group (Group PR; (n) 30 patient) according to a computer-generated randomization list. Premedication was not performed in any of the cases. An ante-cubital vein was cannulated for intravenous infusions and drug administration. In group R, remifentanil was diluted in 0.9% physiological saline (concentration of 40 µg.mL-1) and administered at 0.2 µg/kg bolus dose, followed by a 0.05 µg/kg/min infusion. Meanwhile, in group PR, a mixture of 10 µg.mL-1 remifentanil and 10 mg.mL-1 propofol was administered via a PCAS device. In the PCAS device the initial loading dose was set at 2.5 mL (25 mg propofol – 25 µg remifentanil) and the bolus dose was set at 1 mL (10 mg propofol–10 µg remifentanil). The lockout time was not set. The patients from group PR were instructed about using the PCAS (Abbott Pain Manager; Abbott Laboratories, Chicago, IL, USA) device during the preanesthetic evaluation.
Baseline hemodynamic values were recorded before the procedure. Electrocardiogram (ECG), peripheral oxygen saturation (SpO2), noninvasive arterial pressure, respiratory rate (RR), Visual Analog Scale (VAS) (0; no pain; 10; severe pain), and Ramsey sedation score (RSS) (1;anxious and agitated; 2;cooperative; 3;responding to verbal commands; 4;responding to minor stimulation; 5;responding to deep stimulation; and 6;no response to stimulation) values were recorded every 5 minutes during the procedure. The presence of anxiety in patients was noted as “yes” or “no.”
All patients were informed about VAS prior to the procedure. VAS scores were assessed as follows: 1–3, mild pain; 4–7, moderate pain; and score greater than 7, severe pain. A sufficient sedation level for this study was determined as 2–3 according to RSS. Patients were asked to indicate the severity of pain during the procedure.
The patients were given 2 L/min oxygen via a face mask then the radiologist administered local anesthetics (2% prilocaine at 3 mg/kg dose) to all patients subcutaneously in addition to intravenous sedation and analgesia.
When VAS scores were 4, 10 µg remifentanil as an intravenous bolus dose in group R and 10 µg remifentanil–10 mg propofol from PCAS devices in group PR were administered. In both the groups, patients whose RSS was 1 received 1 mg dose of midazolam (Dormicum, Roche, Germany) for additional sedation. Naloxone hydrochloride and flumazenil were available during all the procedures. An experienced radiologist carried out all of the procedures.
During the procedure and in the recovery room, heart rate (HR), mean arterial pressure (MAP) and SpO2 was recorded at 5-minute intervals after getting basal values.
Hypotension, bradycardia, desaturation, apnea, nausea, vomiting, euphoria, and shivering were recorded as intraoperative and postoperative complications.
If the saturation decreased below 90%, oxygen given via the face mask was increased at a rate of 4 L/min in both the groups, the infusion was stopped in group R, and 1 minute lockout time was set in group PR. The patient was awakened with tactile stimulation or with a loud noise. The head was positioned accordingly.
A plan to treat the patients who developed bradycardia with 0.5 mg atropine was prepared. Meanwhile, the patients who developed hypotension and did not respond to the increased fluid infusion were planned to be treated with 5–10 mg ephedrine. Moreover, metoclopramide, which is an antiemetic drug, was planned for the treatment of nausea and vomiting. Drug infusion was continued until the end of the procedure. After the procedure, the patients were taken to the recovery room, and after a 5-minute break, their noninvasive arterial pressure, HR, SpO2, and modified Aldrete score (MAS) (6) were measured and recorded. The patient vital signs were measured at 5-minute intervals while patients were awake (MAS; 10) for at least 30 minutes in the recovery room.
Prior to discharge, the patients were asked to grade their satisfaction of the applied anesthesia technique by using a 6-point satisfaction scale (0;very poor; 1;poor; 2;moderate; 3;good; 4;very good; 5;excellent). At the end of the process the same scale was used to assess the satisfaction of the radiologists. Then, the patients were discharged with a companion.
The Student's t test was used to compare the differences between the groups for the parametric data. The chi-square test was used for nonparametric data. The two-way analysis of variance test was used to assess the change based on time. P small 0.05 was considered statistically significant.
Intervention code [1] 298618 0
Treatment: Drugs
Intervention code [2] 298619 0
Prevention
Comparator / control treatment
REMIFENTANIL INFUSION
Control group
Active

Outcomes
Primary outcome [1] 302762 0
Pain assessed using Visual Analog Scale (VAS)
Timepoint [1] 302762 0
Visual Analog Scale (VAS) (0;no pain; 10;severe pain),
Baseline values were recorded before the procedure and values were recorded every 5 minutes during the procedure
Primary outcome [2] 303061 0
Sedation assessed Ramsey Sedation Score (RSS) values during the procedure.
Timepoint [2] 303061 0
Ramsey sedation score (RSS) (1;anxious and agitated; 2;cooperative; 3;responding to verbal commands; 4;responding to minor stimulation; 5;responding to deep stimulation; and 6;no response to stimulation) values were recorded every 5 minutes during the procedure.
Primary outcome [3] 303062 0
Anxiety levels assessed before the procedure and after drug administration in both the groups
Because anxiety levels were 1 before the procedure and 0 after drug administration in all patients, test was not used.
(1; yes, 0; no)
Timepoint [3] 303062 0
The assessed of anxiety in patients was noted as “yes” or “no.”
answers recorded before the procedure and after drug administration
Secondary outcome [1] 336932 0
After the procedure, the patients were taken to the recovery room, and modified Aldrete score (MAS) were measured and recorded.
Timepoint [1] 336932 0
The modified Aldrete score (MAS) was measured at intervals of 5 minutes until the patient was awake (MAS = 10)
Consciousness
Fully awake [2 points]
Arousable [1 point]
Not responding [0 points]
Mobility
Able to move four extremities on command [2 points]
Able to move two extremities on command [1 point]
Able to move 0 extremities on command [0 points]
Breathing
Able to breathe deeply [2 points]
Dyspnea [1 point]
Apnea [0 points]
Circulation
Systemic BP 20% of the preanesthetic level [2 points]
Systemic BP between 20% and 49% of the preanesthetic level [1 point]
Systemic BP 50% of the preanesthetic level [0 points]
Color
Normal [2 points]
Pale, jaundiced, blotchy [1 point]
Cyanotic [0 points]
O2 saturation
Maintaining O2 saturation higher than 90% on room air [2 points]
Needs inhalation to maintain O2 saturation >90% [1 point]
O2 saturation below 90% despite O2 supplementation [0 points]
Secondary outcome [2] 337798 0
Hypotension, bradycardia, desaturation, apnea, nausea, vomiting, euphoria, and shivering were recorded as intraoperative and postoperative complications.
this is a composite secondary outcome
Timepoint [2] 337798 0
Hypotension, bradycardia, desaturation, apnea, nausea, vomiting, euphoria, and shivering were recorded as intraoperative and postoperative complications.
Complications recorded from commencement of procedure until 24 hours post procedure completion
Secondary outcome [3] 337799 0
The patients were asked to grade their satisfaction of the applied anesthesia technique by using a 6-point satisfaction scale at the end of the procedure
Timepoint [3] 337799 0
6-point satisfaction scale (0:very poor; 1:poor; 2:moderate; 3:good; 4:very good; 5:excellent).
it was assessment at completion of the procedure,
Secondary outcome [4] 338120 0
Heart rate assessment with Electrocardiogram (ECG)
Timepoint [4] 338120 0
During the procedure and in the recovery room, heart rate was recorded at 5-minute intervals after getting basal values.
Secondary outcome [5] 338121 0
Peripheral oxygen saturation (SpO2) recorded with Pulse oximetry
Timepoint [5] 338121 0
During the procedure and in the recovery room, SpO2 was recorded at 5-minute intervals after getting basal values.
Secondary outcome [6] 338122 0
Mean arterial pressure assessment with noninvasive arterial pressure
Timepoint [6] 338122 0
During the procedure and in the recovery room, mean arterial pressure (MAP) was recorded at 5-minute intervals after getting basal values.

Eligibility
Key inclusion criteria
This study included patients between 18 and 70 years of age who had ASA I–III and were undergoing interventional radiology procedures for diagnostic and treatment purposes.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who had allergic reaction to medications to be used, patients with serious cardiovascular and respiratory system diseases, obesity, sleep apnea syndrome, high risk of pulmonary aspiration, or pregnancy, patients who were unable to grasp the meaning of PCAS, and unaccompanied patients were excluded from the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The Student's t test was used to compare the differences between the groups for the parametric data. The chi-square test was used for nonparametric data. The two-way analysis of variance test was used to assess the change based on time. P below 0.05 was considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/07/2009
Date of last participant enrolment
Anticipated
Actual
29/11/2009
Date of last data collection
Anticipated
Actual
29/11/2009
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 9059 0
Turkey
State/province [1] 9059 0
KONYA

Funding & Sponsors
Funding source category [1] 296999 0
University
Name [1] 296999 0
Necmettin Erbakan University Medical Faculty
Country [1] 296999 0
Turkey
Funding source category [2] 297000 0
Hospital
Name [2] 297000 0
University of Necmettin Erbakan Medical Faculty
Country [2] 297000 0
Turkey
Primary sponsor type
University
Name
University of Necmettin Erbakan, Medical Faculty
Address
Yunus Emre Mah. Baglarbasi Sok. No;281 42080 Meram - KONYA
Country
Turkey
Secondary sponsor category [1] 296006 0
None
Name [1] 296006 0
Address [1] 296006 0
Country [1] 296006 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298196 0
Necmettin Erbakan University Medical Faculty
Ethics committee address [1] 298196 0
Ethics committee country [1] 298196 0
Turkey
Date submitted for ethics approval [1] 298196 0
18/06/2009
Approval date [1] 298196 0
26/06/2009
Ethics approval number [1] 298196 0
2009/357

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76294 0
A/Prof Sule Arican
Address 76294 0
University of Necmettin Erbakan Medical Faculty, Yunus Emre Mah. Baglarbasi Sok. No;281 42080 Meram - KONYA
Country 76294 0
Turkey
Phone 76294 0
+905056259436
Fax 76294 0
Email 76294 0
[email protected]
Contact person for public queries
Name 76295 0
Ruhiye Reisli
Address 76295 0
University of Necmettin Erbakan Medical Faculty ,Yunus Emre Mah. Baglarbasi Sok. No;281 42080 Meram - KONYA
Country 76295 0
Turkey
Phone 76295 0
+903322236000
Fax 76295 0
Email 76295 0
[email protected]
Contact person for scientific queries
Name 76296 0
Ruhiye Reisli
Address 76296 0
University of Necmettin Erbakan Medical Faculty ,Yunus Emre Mah. Baglarbasi Sok. No;281 42080 Meram - KONYA
Country 76296 0
Turkey
Phone 76296 0
+903322236000
Fax 76296 0
Email 76296 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.