NCT03139591

Comparison Between Lidocaine Inhalation and Intravenous Dexamethasone in Reducing Pain After Laryngeal Mask Insertion

Comparison Between Lidocaine Inhalation and Intravenous Dexamethasone to Reduce Pain After Laryngeal Mask Insertion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 20 Years – 59 Years
• Healthy volunteers: Accepted

Summary

This study aimed to compare the efficacy between lidocaine inhalation vs intravenous dexamethasone to reduce pain after laryngeal mask insertion

Detailed description

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups (Lidocaine inhalation and Intravenous dexamethasone group). Intravenous (IV) cannula (18 or 20 G) , non-invasive blood pressure monitor, and pulse-oxymetry had been set on the subjects 10 minutes before anesthesia began. Vital signs were recorded. Lidocaine group received 1.5 mg/kg body weight (BW) of 2% lidocaine inhalation, diluted with 2-3 ml of normal saline until the total volume was 6 ml, and intravenous normal saline injection. Dexamethasone group received normal saline inhalation and 10 mg of intravenous dexamethasone. Subjects, authors, or inhalation giver were not aware of the content of any drug given. Coinduction was done using 0.05mg/kg BW of midazolam and 2mcg/kg BW of fentanyl 5 minutes before the laryngeal mask airway (LMA) insertion. Induction was done using 2 mg/kg BW of 1% propofol and 0.5 mg/kg BW of atracurium 3 minutes before LMA insertion. Subjects were then given oxygenation using face mask without oropharyngeal airway. LMA was lubricated with normal saline. After 3 minutes of oxygenation, LMA was inserted using standard method. The LMA cuff was inflated with cuff pressure gauge of approximately 40 mmHg. After the position of LMA was confirmed to be correct, fixation was done using a tape. Maintenance of anesthesia was done using 50% oxygen in compressed air, 1% isoflurane, and atracurium. Thirty minutes before the surgery ended, 1 gram of paracetamol was given in 15 minutes as post-surgery analgetic. After the surgery was ended, subjects were given 0.04 mg/kg BW of neostigmine and 0.02 mg/kg BW of atropine. Mucus suction was performed on oropharynx and oral cavity gently, by using suction catheter 12F when subjects were still under anesthesia. After spontaneous breaths occured, LMA cuff was deflated and LMA was removed. Ventilation was continued using face mask without oropharyngeal airway. At the recovery room, pain on throat was assessed using Numerical Rating Scale. Assessment was done 2 hours after surgery in the recovery room after subjects were fully alert with Aldrette score of 10. Throat pain was assessed during rest or swallowing. In addition, subjects were asked whether or not they experienced difficulty in swallowing or hoarseness.

Conditions

• Adult Patients Undergoing Elective Surgery With General Anesthesia and LMA Insertion

Interventions

Type	Name	Description
DRUG	lidocaine inhalation; intravenous dexamethasone	1.5 mg/kg body weight (BW) of 2% lidocaine inhalation, diluted with 2-3 ml of normal saline until the total volume was 6 ml, and intravenous normal saline injection; Intravenous dexamethasone group: normal saline inhalation and 10 mg of intravenous dexamethasone.

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-01-31
• Completion: 2017-05-31
• First posted: 2017-05-04
• Last updated: 2017-08-18

Locations

1 site across 1 country: Indonesia