The Effect of Dexmedetomidine Versus Lidocaine on Emergence Agitation.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexmedetomidine, Lidocaine.
- Who it may be relevant to
- Registry conditions: Emergence Agitation. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Intravenous Dexmedetomidine Versus Intravenous Lidocaine on the Emergence Agitation After Endoscopic Sinus Surgery. A Prospective, Randomized, Double-blind Controlled Trial.
Overview
The effect of intravenous dexmedetomidine versus intravenous lidocaine on the emergence agitation after endoscopic sinus surgery.
Detailed description
Endoscopic sinus surgery (ESS) is a common operation for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) when medical therapy alone is insufficient .
Early recovery from general anesthesia is accompanied by agitation, confusion, disorientation, and violent behavior, which is known as Emergence Agitation (EA). This post-anesthetic issue occurs in the early stages of General Anesthesia (GA) recovery, posing challenges in terms of both patient recovery delay and the complexities associated with assessment and management.
The incidence of EA varies, from approximately 0.25% to 90.5%, with age, assessment tool used, definitions, anesthetic techniques, type of surgery, and time of EA assessment during recovery .
Because the airway is contaminated with blood and the nasal airway is closed with surgical packs. ENT surgery is linked to a higher incidence of emerging agitation after nasal surgery.
Although EA is commonly self-limited and happens within the first 30 min of stay in a postanesthesia care unit (PACU) and also can lead to disconnection of monitoring devices or intravenous catheters, physical damage, falling, increase in the risk of bleeding, and self-extubation .
Several pharmacological methods have been used to mitigate EA, including opioid (fentanyl, remifentanil), propofol, benzodiazepine (midazolam), α2- aderenoreceptor agonist (clonidine, dexmedetomidine), and N-methy-d-aspar- tate (NMDA) receptor antagonist (ketamine, magnesium sulfate) administration.
Lidocaine is an amino amide-type short-acting local anesthetic (LA). It has a short half-life, and a favorable safety profile, and is therefore the LA of choice for continuous IV administration. Systemic lidocaine has been shown to be an effective adjunct strategy to reduce postoperative pain.
Dexmedetomidine is known as a highly selective α (2)-adrenoceptor agonist with sedative, anxiolytic, sympatholytic, and analgesic-sparing effects, which causes minimal depression of the respiratory function.
Interventions
- Drug Dexmedetomidine
Group (D) recieves Dexmedetomidine bolus 1mcg/kg over 10 minutes before induction of anesthesia followed by continous infusion at 0.4 mcg/kg/h until the end of surgery - Drug Lidocaine
Group (L) recieves IV lidocaine 1.5 mg/kg slowly before induction of anesthesia then lidocaine infusion starts at a rate of 2mg/kg/h
Primary outcome measures
- Incidence of emergence agitation (EA) . [Time frame: Immediate after extubation]
Secondary outcome measures (12)
- heart rate (beats per minute ) [Time frame: baseline ( preoperative )]
- heart rate (beats per minute ) [Time frame: after 30 minutes ( intraoperative)]
- heart rate (beats per minute) [Time frame: after 60 minutes ( intraoperative )]
- heart rate (beats per minute) [Time frame: 0 hour postoperative]
- heart rate (beats per minute) [Time frame: 1 hour postoperative]
- heart rate (beats per minute) [Time frame: 3 hours postoperative]
- heart rate (beats per minute) [Time frame: 6 hours postoperative]
- heart rate (beats per minute) [Time frame: 12 hours postoperative]
- heart rate (beats per minute) [Time frame: 24 hours postoperative]
- Mean arterial blood pressure (mmHg) [Time frame: baseline ( preoperative )]
- Mean arterial blood pressure (mmHg) [Time frame: after 30 minutes ( intraoperative )]
- Mean arterial blood pressure (mmHg) [Time frame: after 60 minutes ( intraoperative )]
Eligibility criteria
Inclusion criteria
- Age : 18-60
- ASA Physical Status I or II
- Elective endoscopic sinus surgery under general anesthesia .
Exclusion criteria
- Refusal to participate
- Mental retardation or inability to communicate
- Allergy to anesthetics or study medications .
- Chronic use of beta blockers .
- significant hepatic, neurologic, cardiovascular or respiratory disease .
- BMI>35 kg/m2
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- FayoumU — Al Fayyum
Publications
- Mohkamkar M Bs, Farhoudi F Md, Alam-Sahebpour A Md, Mousavi SA Md, Khani S PhD, Shahmohammadi S BSc. Postanesthetic Emergence Agitation in Pediatric Patients under General Anesthesia. Iran J Pediatr. 2014 Apr;24(2):184-90. PMID 25535538
- Lourijsen ES, Reitsma S, Vleming M, Hannink G, Adriaensen GFJPM, Cornet ME, Hoven DR, Videler WJM, Bretschneider JH, Reinartz SM, Rovers MM, Fokkens WJ. Endoscopic sinus surgery with medical therapy versus medical therapy for chronic rhinosinusitis with nasal polyps: a multicentre, randomised, controlled trial. Lancet Respir Med. 2022 Apr;10(4):337-346. doi: 10.1016/S2213-2600(21)00457-4. Epub 202 PMID 35012708
Identifiers
NCT: NCT07355049 · M786