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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] 282406 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anesthesiology for thyroidectomy. 288988 0
Condition category
Condition code
Anaesthesiology 289329 289329 0 0
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] 287039 0
Treatment: Drugs
Comparator / control treatment
100 ml of normal saline
Control group
Placebo

Outcomes
Primary outcome [1] 289443 0
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] 289443 0
at the end of surgery
Secondary outcome [1] 302486 0
extubation time, the time interval from cessation of sevoflurane inhalation to tracheal extubation
Timepoint [1] 302486 0
after completion of surgery
Secondary outcome [2] 302536 0
postoperative pain score by using a visual analogue scale (VAS)
Timepoint [2] 302536 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
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] 5049 0
Saudi Arabia
State/province [1] 5049 0

Funding & Sponsors
Funding source category [1] 287178 0
Self funded/Unfunded
Name [1] 287178 0
dr. waleed m abdelmageed
Address [1] 287178 0
King Abdulaziz Naval Base Hospital, Jubail 31951, Saudi Arabia
PO Box413
Country [1] 287178 0
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] 285943 0
None
Name [1] 285943 0
Address [1] 285943 0
Country [1] 285943 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289174 0
Research and Ethics Committee, King Abdulaziz Naval Base Hospital.
Ethics committee address [1] 289174 0
King Abdulaziz Naval Base Hospital, Jubail 31951, Saudi Arabia
PO Box413
Ethics committee country [1] 289174 0
Saudi Arabia
Date submitted for ethics approval [1] 289174 0
16/04/2011
Approval date [1] 289174 0
16/04/2011
Ethics approval number [1] 289174 0

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 39602 0
A/Prof Waleed M. Abdelmageed
Address 39602 0
King Abdulaziz Naval Base Hospital, Jubail 31951
PO Box 413
Country 39602 0
Saudi Arabia
Phone 39602 0
+966557189366
Fax 39602 0
Email 39602 0
walidabdelmageed@yahoo.com
Contact person for public queries
Name 39603 0
A/Prof Waleed M. Abdelmageed
Address 39603 0
King Abdulaziz Naval Base Hospital, Jubail 31951
PO Box 413
Country 39603 0
Saudi Arabia
Phone 39603 0
+966557189366
Fax 39603 0
Email 39603 0
walidabdelmageed@yahoo.com
Contact person for scientific queries
Name 39604 0
A/Prof Waleed M. Abdelmageed
Address 39604 0
King Abdulaziz Naval Base Hospital, Jubail 31951
PO Box 413
Country 39604 0
Saudi Arabia
Phone 39604 0
+966557189366
Fax 39604 0
Email 39604 0
walidabdelmageed@yahoo.com

No information has been provided regarding IPD availability
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