ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613000485730

Ethics application status

Approved

Date submitted

29/04/2013

Date registered

1/05/2013

Date last updated

6/05/2013

Type of registration

Retrospectively registered

Titles & IDs

Public title

The use of intravenous paracetamol (acetaminophen) infusion before the start of general anesthesia with spectral entropy monitoring decreases consumption of the inhalational anesthetic sevoflurane in patients undergoing thyroidectomy surgery.

Scientific title

Preoperative paracetamol (acetaminophen) infusion reduces sevoflurane consumption during thyroidectomy under general anesthesia with spectral entropy monitoring

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

anesthesiology for thyroidectomy.

Condition category

Condition code

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Before the start of anesthesia, the patients were randomized, by using a computer generated random list to one of two groups; the Paracetamol group (Group P) and the Control group (Group C). All patients received a slow IV infusion over 15 min just before induction of anesthesia of either 1 gm paracetamol (Perfalgan 10 mg ml-1, 100 ml vial; UPSA, France) (Group P, n=31) or 100 ml of normal saline (Group C, n=31). Extubation time, time to eye opening to command, time to state his/her name and time to correctly mention his/her date of birth (assessed at 60 sec intervals) were noted and taken from cessation of sevoflurane inhalation. Sevoflurane consumption was estimated for each patient. Pain intensity was assessed immediately by the nurses who were blinded to the treatment group using a VAS, and was re-assessed again before leaving the PACU after 30 min, then in the surgical ward, every 30 min till the end of the 6th PO hour

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

100 ml of normal saline

Control group

Placebo

Outcomes

Primary outcome [1]

The primary outcome of this study was the sevoflurane end-tidal concentration which was recorded from the anesthesia monitor at regular interval throughout the operation and the sevoflurane consumption in the 2 groups, which was estimated by the “vaporizer weighing method” in which the vaporizer was filled to maximum and weighed before induction of anesthesia, then reweighed again at the completion of surgery. By knowing the specific weight of sevoflurane (1.52 kg L-1)16; the volume of the consumed liquid sevoflurane was estimated.

Timepoint [1]

at the end of surgery

Secondary outcome [1]

extubation time, the time interval from cessation of sevoflurane inhalation to tracheal extubation

Timepoint [1]

after completion of surgery

Secondary outcome [2]

postoperative pain score by using a visual analogue scale (VAS)

Timepoint [2]

Pain intensity was assessed immediately on admission to PACU by the nurses who were blinded to the treatment group using a VAS, and was re-assessed again before leaving the PACU after 30 min, then in the surgical ward, every 30 min till the end of the 6th PO hour.

Eligibility

Key inclusion criteria

ASA physical status I and II patients of both sex, scheduled for subtotal thyroidectomy under general anesthesia.

Minimum age

20 Years

Maximum age

55 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

known allergy to paracetamol, neurological or psychological diseases, impaired liver functions (ALT > twice the normal value) and impaired renal function (serum creatinine >2.0 mg %). Exclusion criteria also included pregnancy and breast feeding, the chronic use of analgesics or drugs affecting the central nervous system (CNS) function, the use of paracetamol within 6 hours or any other analgesic medication within 12 hours before the operation.

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

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

7/05/2011

Actual

7/05/2011

Date of last participant enrolment

Anticipated

26/02/2013

Actual

26/02/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Saudi Arabia

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

dr. waleed m abdelmageed

Address [1]

King Abdulaziz Naval Base Hospital, Jubail 31951, Saudi Arabia
PO Box413

Country [1]

Saudi Arabia

Primary sponsor type

Individual

Name

dr. waleed m abdelmageed

Address

King Abdulaziz Naval Base Hospital, Jubail 31951, Saudi Arabia
PO Box413

Country

Saudi Arabia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Research and Ethics Committee, King Abdulaziz Naval Base Hospital.

Ethics committee address [1]

King Abdulaziz Naval Base Hospital, Jubail 31951, Saudi Arabia
PO Box413

Ethics committee country [1]

Saudi Arabia

Date submitted for ethics approval [1]

16/04/2011

Approval date [1]

16/04/2011

Ethics approval number [1]

Summary

Brief summary

Proper monitoring of the depth of anesthesia is crucial for judicious titration of anesthetics to prevent awareness under general anesthesia as well as the side effects of anesthetic over-dose with the subsequent economic waste and environmental pollution. With awareness, the patient may exhibit symptoms ranging from mild anxiety to post traumatic stress disorder (sleep disturbances, nightmares and social difficulties). In the standard clinical practice, the depth of anesthesia is judged by the clinical experience of the anesthetist based on the patient’s vital signs and the hemodynamic responses. However the regular use of certain medications as beta-blockers and antihypertensive drugs render the hemodynamic signs unreliable for titration of anesthetics.
At present; the electroencephalogram (EEG) based spectral entropy is increasingly being used for monitoring the depth of anesthesia and provides information regarding the cortical state of the patient and the level of hypnosis as well as an indirect measure of the adequacy of analgesia. The monitor uses different algorithms to calculate the level of consciousness index by processing the EEG signal measured over the forehead and drive the numeric index. The spectral entropy has 2 signals: State entropy (SE) which reflects the hypnotic level of the patient; computed from an EEG data from the previous 15 sec in the range of 0.8 to 32 Hz, and shows the value in the range of 0 – 91 and Response entropy (RE) that includes; in addition to the EEG, a forehead muscle electromyography component and reflects the patient arousal and response to painful stimuli. The latter is computed from an EEG data in the range of 0.8 to 47 Hz and shows the value in the range of 0 – 100. Entropy values between “40 – 60” are the recommended surgical level of anesthesia while “100” signifies awake state and “0” indicates suppression of  the cortical neuronal activity.
Intravenous (IV) paracetamol (acetaminophen in USA) is an effective analgesic and antipyretic agent acting at both the central and peripheral components of the pain pathway and devoid of the detrimental effects of opioids and non-steroidal anti-inflammatory drugs (NSAID) with a tolerability profile similar to placebo. The onset of paracetamol analgesia starts rapidly after 5 – 10 min of IV administration, with peak effect obtained within 1 hour and lasting 4 – 6 hours. Thus, IV paracetamol is a suitable medication for the treatment of postoperative pain when used either alone or as a part of a balanced analgesic regimen. In addition, several studies in the medical literature have demonstrated the opioid-sparing effect of IV paracetamol. In view of these reports, we hypothesized that preoperative infusion of IV paracetamol would decrease sevoflurane consumption during general anesthesia. To explore this; we utilized spectral entropy monitoring to evaluate the effect of the preoperative administration of IV paracetamol on  sevoflurane consumption in patients undergoing thyroidectomy under general anesthesia.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Waleed M. Abdelmageed

Address

King Abdulaziz Naval Base Hospital, Jubail 31951
PO Box 413

Country

Saudi Arabia

Phone

+966557189366

Fax

walidabdelmageed@yahoo.com

Contact person for public queries

Name

Waleed M. Abdelmageed

Address

King Abdulaziz Naval Base Hospital, Jubail 31951
PO Box 413

Country

Saudi Arabia

Phone

+966557189366

Fax

walidabdelmageed@yahoo.com

Contact person for scientific queries

Name

Waleed M. Abdelmageed

Address

King Abdulaziz Naval Base Hospital, Jubail 31951
PO Box 413

Country

Saudi Arabia

Phone

+966557189366

Fax

walidabdelmageed@yahoo.com

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

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Preoperative paracetamol infusion reduces sevoflurane consumption during thyroidectomy under general anesthesia with spectral entropy monitoring	2014	https://doi.org/10.1016/j.egja.2013.12.003

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

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