Comparing Efficacy Preoperative Nebulized: Ketamine , Mgspo4 ,and Lidocaine In Attenuating Endotracheal Sore Throat
Condition: Sore Throat
MeSH terms: Pharyngitis
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Ketamine; Magnesium Sulfate; Lidocaine; Normal saline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Patients nebulized ketamine by compressor nebulizing for 15 minutes.; Patients nebulized magnesium sulfate 250mg (3ml)plus 2ml normal saline by compressor nebulizing for 15 minutes.; In preparation room an I.V line was secured ,and standard monitoring was connected to patient.
Patients nebulized lidocaine 5ml by compressor nebulizing for 15 minutes.; In preparation room an I.V line was secured ,and standard monitoring was connected to patient.
Patients nebulized by compressor nebulizing 5ml normal saline for 15 minutes.
Other intervention name(s): (Ketalar, 50 Mg/mL Injectable Solution); (Magnesium Sulfate 500 /ML); (Xylocaine 2 % Injectable Solution); (Normal Saline 0.9% Infusion Solution)
Intervention MeSH terms: Lidocaine; Magnesium Sulfate; Ketamine; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention