A Phase 4 interventional study of Ketamine and Lidocaine in Anesthesia, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 21 Years to 50 Years. Per ClinicalTrials.gov, last updated 2019-11-26.
Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment
This randomized double-blinded study is performed to compare ketamine versus lidocaine for nebulization for awake nasal fiberoptic intubation as regard efficacy and side effects.
Difficult airway is one of the major challenges facing anesthesiologists. This challenge is compounded when the patient is treated while awake. The additional burden is to complete this procedure comfortably thus ensuring patient cooperation which is a vital part of successful performance. Several methods have been tried in literature to facilitate awake intubation by fiberoptic bronchoscope (FOB)
This randomized double-blinded study is performed to compare ketamine versus lidocaine for nebulization for awake nasal fiberoptic intubation as regard efficacy and side effects.
Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nebulization with ketamine
Drug: Ketamine
Nebulization with with lidocaine
Drug: Lidocaine
While in the semi-setting position, patients will receive nebulization with ketamine 3 mg/kg to be completed with normal saline solution to reach a volume of 6 ml (K group; n=30) for 15 minutes before commencing the awake fiberoptic intubation..
Also known as: Ketalar
While in the semi-setting position, patients will receive nebulization with lidocaine 4% 6 ml (L group; n=30) for 15 minutes before commencing the awake fiberoptic intubation
Also known as: xylocaine
Dose of supplemental lidocaine
Dose of supplemental lidocaine during awake fiberoptic procedure
Time frame: Intraoperative
Incidence of adverse events
The incidence of adverse events related to the procedure and study drugs will be recorded
Time frame: Intraoperative
Patient satisfaction score
will be assessed against five point Likert score where (1: poor, 2: fair, 3: good, 4: very good, 5: excellent).
Time frame: first 24 hours
Patient tolerability score
Patient tolerability during the procedure will be rated as 4-point scale where 0= procedure totally intolerable with severe patient resistance (struggling/withdrawal movements). 1. procedure partially tolerable with moderate patient resistance (restlessness/ verbal objection). 2. procedure quiet tolerable with minimal patient resistance (just grimacing). 3. procedure tolerable with no patient resistance. this score will be recorded at points during the intubation procedure: nasal passage, oro/hypopharynx, glottis and tube insertion.
Time frame: Intraoperative
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Jul 2019, 18 months.
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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ketamine · Lidocaine