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Trial registered on ANZCTR


Registration number
ACTRN12614000890639
Ethics application status
Approved
Date submitted
6/08/2014
Date registered
21/08/2014
Date last updated
28/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effects of Bispectral Index Monitoring on Hemodynamics and Recovery Profile in Mentally Retarded Pediatric Patients Undergoing Dental Surgery
Scientific title
The Effects of Bispectral Index Monitoring on Hemodynamics and Recovery Profile in Mentally Retarded Pediatric Patients Undergoing Dental Surgery: A prospective randomized Clinical Trial
Secondary ID [1] 285115 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesiology for dental surgery in mentally retarded pediatric patients 292673 0
Condition category
Condition code
Anaesthesiology 292984 292984 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Forty children between the ages of 6-16 yr, ASA physical status I,II and III, scheduled to undergo dental rehabilitation under general anesthesia, were studied in this prospective and randomized study. Patients with moderate mental retardation were also enrolled in this study.
The children were randomized, by using a computer-generated block randomisation, into 2 groups. In Group 1 (n=20), the depth of anesthesia was monitored by the Bispectral index (BIS) and BIS scores was maintained between 45-65 by titrated sevoflurane. In Group 2 (n=20), BIS monitoring was not performed, and general anesthesia was maintained with one minimum alveolar concentration (MAC) of sevoflurane in oxygen by hemodynamic parameters.
All patients were expected to fast 6-8 hours before dental surgery, and no one premedicated. Routine monitors (consisting of a pulse oximeter, 3-lead ECG and a non-invasive blood pressure cuff and BIS monitoring only group 1) were applied. Baseline measurements were obtained and 3 min of pre-oxygenation was performed before the induction of general anaesthesia.
In both groups general anesthetic management consisted of face mask inhalation induction with sevoflurane 8% in oxygen and then intravenous (IV) catheter placed. Intravenous rocuronium 0.6 mg/kg was given to facilitate tracheal intubation. After, making sure that all four TOF responses of the Adductor Pollicis disappeared intubation (with an appropriately sized nasotracheal tube) was then performed.
After induction, volume controlled mechanical ventilation (tidal volume adjusted to 6-8 mL/kg with no application of positive end expiratory pressure and respiratory rates were adjusted to achieve an end-tidal carbon dioxide of 30 to 35 mm Hg.) was initiated. Anaesthesia was maintained using sevoflurane in an oxygen / air mixture and remifentanil (0,25 microg/kg/min). When mean blood pressure (MBP) varied by more than +/- 20% from the baseline the infusion rate of crystalloid solution was increased. If this was not sufficient, the inspired anesthetic concentration was reduces and anesthesia was maintained in this way in Group 2. In group 1, anesthesia was maintained by BIS scores between 45-65. Paracetamol (10 mg/kg) were given IV to attenuate postoperative pain.
BIS score, HR, BP, oxygen saturation (SpO2), ETCO2 and TOF values was continuously recorded from awake status to tracheal extubation (basal, after induction, after intubation, at the start of surgery, every 10 minutes during surgery, at the end of surgery, during eye opening in response to verbal stimulus or painful pinching and after extubation).
Remifentanil infusion stopped and all patients were weaned of sevoflurane as the surgery neared conclusion (when started control of bleeding). Hence, when the surgery ended, it coincided with the sevoflurane being turned off. Sugammadex (2mg/kg) was used for neuromuscular recovery in all patients when anesthesic agents turned off. When neuromuscular recovery was completed and adequate depth of breathing was reached (after the return of adequate ventilator drive, tidal volume > 6 ml/kg, respiratory rate > 12/min, normal breathing patterns and good oxygenation [SpO2 > 98%]) tracheal extubation was done. Following tracheal extubation, patients were cared for in the recovery room. In the PACU, the criteria for discharge (which included consciousness, normal vital signs, no pain and no nausea or vomiting) was the same for all patients. For measuring pain, Non-communicating Children’s Pain Checklist – Revised (NCCPC-R) was used in PACU. This pain score was noted. A total Score of 7 or more indicates a child has pain and a non steroidal anti inflammatory drug (0,4 mg/kg) were given IV to attenuate pain.
The duration of the surgical procedure (skin incision to skin closure), anesthesia (time of induction to time of discontinuation of anesthetic agents), PACU stay was noted. To evaluate recovery profile time to spontaneous ventilation (the time between anesthetic discontinuation and beginning of spontaneous ventilation), extubation (the time between anesthetic discontinuation and extubation), open eyes (the time between anesthetic discontinuation and eye opening in response to verbal stimulus or painful pinching) and PACU discharge was also noted.
Intervention code [1] 289964 0
Treatment: Devices
Comparator / control treatment
Group 2, BIS monitoring was not performed, and general anesthesia was maintained with one minimum alveolar concentration (MAC) of sevoflurane in oxygen by hemodynamic parameters.
Control group
Active

Outcomes
Primary outcome [1] 292844 0
Time to extubation
Timepoint [1] 292844 0
The time between anesthetic discontinuation and extubation.
Secondary outcome [1] 309788 0
Time to spontaneous ventilation
Timepoint [1] 309788 0
The time between anesthetic discontinuation and beginning of spontaneous ventilation.
Secondary outcome [2] 309789 0
Time to open eyes
Timepoint [2] 309789 0
The time between anesthetic discontinuation and eye opening in response to verbal stimulus or painful pinching.
Secondary outcome [3] 309790 0
Time to PACU discharge
Timepoint [3] 309790 0
PACU stay time

Eligibility
Key inclusion criteria
Between the ages of 6-16 yr, ASA physical status I,II and III, scheduled to undergo dental rehabilitation under general anesthesia
Minimum age
6 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient's legal guardians who dont wish to give consent

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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] 6280 0
Turkey
State/province [1] 6280 0

Funding & Sponsors
Funding source category [1] 289722 0
Hospital
Name [1] 289722 0
Konya Training and Research Hospital
Address [1] 289722 0
Konya Training and Research Hospital,Clinic of Anesthesiology and Reanimation, 42090, Meram, Konya
Country [1] 289722 0
Turkey
Primary sponsor type
Hospital
Name
Konya Training and Research Hospital
Address
Konya Training and Research Hospital,Clinic of Anesthesiology and Reanimation, 42090, Meram, Konya
Country
Turkey
Secondary sponsor category [1] 288416 0
None
Name [1] 288416 0
Address [1] 288416 0
Country [1] 288416 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291458 0
Necmettin Erbakan University Meram School of Medicine
Ethics committee address [1] 291458 0
Necmettin Erbakan University Meram School of Medicine Akyokus, Meram,Konya 42080
Ethics committee country [1] 291458 0
Turkey
Date submitted for ethics approval [1] 291458 0
21/03/2014
Approval date [1] 291458 0
26/03/2014
Ethics approval number [1] 291458 0
2014/61

Summary
Brief summary
Forty children between the ages of 6-16 yr, ASA physical status I,II and III, scheduled to undergo dental rehabilitation under general anesthesia, were studied in this prospective and randomized study.
In Group 1 (n=20), the depth of anesthesia was monitored by the BIS and BIS scores was maintained between 45-65 by titrated sevoflurane. In Group 2 (n=20), BIS monitoring was not performed, and general anesthesia was maintained with one minimum alveolar concentration (MAC) of sevoflurane in oxygen by hemodynamic parameters.
In both groups general anesthetic management consisted of face mask inhalation induction with sevoflurane 8% in oxygen and then intravenous (IV) catheter placed.
After induction, volume controlled mechanical ventilation was initiated. Anaesthesia was maintained using sevoflurane in an oxygen / air mixture and remifentanil (0,25 microg/kg/min).
BIS score, HR, BP, oxygen saturation (SpO2), ETCO2 and TOF values was continuously recorded from awake status to tracheal extubation.
Remifentanil infusion stopped and all patients were weaned of sevoflurane as the surgery neared conclusion . Hence, when the surgery ended, it coincided with the sevoflurane being turned off. Following tracheal extubation, patients were cared for in the recovery room. In the PACU, the criteria for discharge was the same for all patients. For measuring pain, Non-communicating Children’s Pain Checklist – Revised (NCCPC-R) was used in PACU.
The duration of the surgical procedure, anesthesia , PACU stay was noted. To evaluate recovery profile time to spontaneous ventilation, extubation, open eyes and PACU discharge was also noted.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50502 0
Dr Mehmet SARGIN
Address 50502 0
Konya Training and Research Hospital, Clinic of Anesthesiology and Reanimation, Meram, Konya Postcode:42090
Country 50502 0
Turkey
Phone 50502 0
+905322662766
Fax 50502 0
Email 50502 0
mehmet21sargin@yahoo.com
Contact person for public queries
Name 50503 0
Prof Sadik OZMEN
Address 50503 0
Konya Training and Research Hospital, Clinic of Anesthesiology and Reanimation, Meram, Konya Postcode:42090
Country 50503 0
Turkey
Phone 50503 0
+903322212250
Fax 50503 0
Email 50503 0
sadikozmen@hotmail.com
Contact person for scientific queries
Name 50504 0
Prof Sadik OZMEN
Address 50504 0
Konya Training and Research Hospital, Clinic of Anesthesiology and Reanimation, Meram, Konya Postcode:42090
Country 50504 0
Turkey
Phone 50504 0
+903322212250
Fax 50504 0
Email 50504 0
sadikozmen@hotmail.com

No data has been provided for results reporting
Summary results
Not applicable