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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]

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

Condition category

Condition code

Anaesthesiology

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]

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]

Time to extubation

Timepoint [1]

The time between anesthetic discontinuation and extubation.

Secondary outcome [1]

Time to spontaneous ventilation

Timepoint [1]

The time between anesthetic discontinuation and beginning of spontaneous ventilation.

Secondary outcome [2]

Time to open eyes

Timepoint [2]

The time between anesthetic discontinuation and eye opening in response to verbal stimulus or painful pinching.

Secondary outcome [3]

Time to PACU discharge

Timepoint [3]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/04/2014

Actual

1/04/2014

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]

Turkey

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Konya Training and Research Hospital

Address [1]

Konya Training and Research Hospital,Clinic of Anesthesiology and Reanimation, 42090, Meram, Konya

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Necmettin Erbakan University Meram School of Medicine

Ethics committee address [1]

Necmettin Erbakan University Meram School of Medicine Akyokus, Meram,Konya  42080

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

21/03/2014

Approval date [1]

26/03/2014

Ethics approval number [1]

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

Dr Mehmet SARGIN

Address

Konya Training and Research Hospital, Clinic of Anesthesiology and Reanimation, Meram, Konya Postcode:42090

Country

Turkey

Phone

+905322662766

Fax

[email protected]

Contact person for public queries

Name

Sadik OZMEN

Address

Konya Training and Research Hospital, Clinic of Anesthesiology and Reanimation, Meram, Konya Postcode:42090

Country

Turkey

Phone

+903322212250

Fax

[email protected]

Contact person for scientific queries

Name

Sadik OZMEN

Address

Konya Training and Research Hospital, Clinic of Anesthesiology and Reanimation, Meram, Konya Postcode:42090

Country

Turkey

Phone

+903322212250

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Paediatr Anaesth. 2015 Sep;25(9):950-5. doi: 10.11... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The effects of bispectral index monitoring on hemodynamics and recovery profile in developmentally delayed pediatric patients undergoing dental surgery.	2015	https://dx.doi.org/10.1111/pan.12692

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically