None listed
Conditions
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.
Interventions
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
Sponsors
Study design
Eligibility
Inclusion criteria
ASA physical status I and II patients of both sex, scheduled for subtotal thyroidectomy under general anesthesia.
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.