Sore Throat Clinical Trial
Official title:
Comparing The Efficacy Of Preoperative Nebulized: Ketamine, Magnesium Sulfate, and Lidocaine In Attenuating Postoperative Sore Throat After Endotracheal Intubation
One of the most common complications after endotracheal intubation is sore throat Lidocaine
jelly or spray, preoperative gargles with licorice or ketamine or I.V steroids used for
prophylaxis against POST are expensive ,and having much more side effects,but nebulized
lidocaine is easily found with decreasing cost ,easily administered ,acts immediately with
short duration ,minimal side effects ,and no term residual side effects.
Nebulized ketamine was found to have a protective effect on allergen-induced airway
inflammatory injury , high airway reactivity ,and decreasing postoperative sore throat (POST)
incidence .
Magnesium sulfate is similar to ketamine in blocking the N-methyl-D-aspartate receptors.
Patients and Methods a) Sample size:Assuming that mean+standard Deviation of age of nebulized
ketamine group is 42.3+11.9 and normal saline group is 35.5+11.7 .So sample size is
calculated by open source Epidemiologic statistics for public health (openEpi) to be 100
cases in 4 groups (25 cases in each group) with confidence level 95% and power of test is
80%.
All Cases Will Undergo:
a. Patient Examination: All participating patients will be interviewed preoperatively during
their preoperative preparation. The goal and endpoints of the study will be discussed. and
written informed consent will be included in the study.
On physical examination, special attention will be given to document vital signs, cardiac,
chest condition and exclude exclusion criteria , laboratory investigations will be reviewed
..
In preparation room an I.V line was secured ,and stranded monitoring was connected to
patient.
Patients nebulized by compressor nebulizing for 15 minutes. Patient was then transferred to
operating room where a stranded monitor was connected (Non-invasive blood pressure, pulse
oximeter, ECG,and capnography).
Patient was pre-oxygenated with 5 Litter/min (L/min) O2, 100% for 3-5 min. premedication with
glycopyrrolate 0.01 milgram/kilogram (mg/kg), midazolam 0.02mg/kg.
Induction was done by fentanyl 2ug/kg, propofol 2mg/kg, endotracheal intubation was
facilitated by atracurium 0.6mg/kg, and intubation by soft seal cuffed sterile polyvinyl
chlorid tracheal tube of 7mm inner diameter in female ,and 8mm in male patients, the cuff was
inflated with air.All intubation was performed by an experienced anaesthesiologist.
Maintenance of anaesthesia done using isoflurane 1 Minimum Alveolar Concentration (MAC) ,and
atracurium. The last dose of atracurium was given 20 min. before extubation.
At the end of the surgery, the inhalational anaesthetic was turned off, and the muscle
relaxant was reversed by a combination of neostigmine 0.05mg/kg, and glycopyrrolate
0.01mg/kg.The patient was extubated after extubation criteria were met, and the patient was
transferred to recovery room.
In the recovery room, all patients received O2 2.5L/min by face mask.The presence of sore
throat was noted at rest and on swallowing immediately after extubation.
The intensity of sore throat was recorded at 2,4,8,12,24 hours postoperatively. In
postoperative ward, patients were also monitored haemodynamics (BLp, O2 saturation, pulse),
drug related side effects,and sedation level using A=Alert, V=Verbal,
P=Painful,U=Unresponsive ( AVPU)score .
Sore throat was measured on 4 point scale (0-3). 0= no sore throat
1. mild sore throat (complaint of sore throat on asking).
2. moderate sore throat (change in voice or hoarseness associated with throat pain).
3. sever sore throat (change in voice or hoarseness associated with throat pain). Protocol
for pain management, I.V diclofenac 75mg every 12h. Patient with sore throat score = 2
or 3 will be treated with IV diclofenac 1mg/kg every 8h.
Patient satisfaction:The patients will be asked to rate the overall degree of satisfaction of
the analgesia using a 1-3 verbal scale (1 = unsatisfactory analgesia, 2 = satisfactory
analgesia, and 3 = excellent analgesia) .
VII- Side effects and Complications as: Nausea, Vomiting, Local anaesthetics toxicity or
other complications will be documented.
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