Midazolam Effect on Agitation Postnasal Surgery
Condition: Agitation
MeSH terms: Psychomotor Agitation
Study type: Interventional

Summary: 
      Postoperative agitation is a common complication, it's incidence post head and neck surgery
      is around 11-26%. Avoiding such complication is mandatory to facilitate patient's recovery
      and reduce risk of postoperative agitation related complications. Our study aims to detect
      the incidence of agitation following nasal surgery, and to determine the midazolam effect on
      agitation, when administered just before emergence from anesthesia.
    

Detailed description: 
      This is a prospective, single centre, double blinded randomized controlled trial, which was
      conducted from May 2021 to November 2021. An ethical approval was obtained from the local
      research ethical board in the Jordanian Royal Medical Services on May 26, 2021, in addition
      to an informed written consent from every patient. Subjects with American Society of
      Anesthesiologists (ASA) of either grade 1 or 2, aged from 16 to 59 years, undergoing nasal
      surgery such as; septoplasty (SP), open septorhinoplasty (OSRP) and functional endoscopic
      sinus surgery (FESS) were included in the study. A sample size of 100, 50 in each group was
      found to be enough to achieve the study purposes using G*Power computer program, considering
      alpha set at 0.05; medium effect size and study power 80%. Subjects were randomly assigned
      into two groups, midazolam group and placebo group. In the midazolam group, patients double
      blindly received 0.03 mg.kg-1 midazolam intravenously just before emergence from general
      anesthesia. On the other hand, placebo group's patients double blindly received normal saline
      of similar volume to midazolam just before emergence from general anesthesia. A computerized
      random number generator was utilized to provide the codes for midazolam and normal saline
      syringes. Patients otherwise received the same general anesthetic technique, including
      medications and equipments by the same anesthesiologist. The maximum Richmond Agitation
      Sedation Scale (RASS) score, from the time of extubation till patient's handover to
      postanesthesia care unit (PACU) was observed and documented by the same anesthesiologist and
      it was the basis for agitation diagnosis, therefore, the primary outcome was RASS score of +2
      or more.

      Anesthetic technique: No premedication was given to any patient. All patients received
      intravenous fentanyl 1.5 mcg.kg-1, propofol 2 mg.kg-1 and cisatracurium 0.2 mg.kg-1 for
      induction of general anesthesia. This was followed by manual ventilation for 4 minutes and
      intubation. Anesthesia was maintained by 1 MAC (Minimal Alveolar Concentration) of desflurane
      for all patients, in addition to remifentanil infusion (0.02 - 2.0 mcg.kg-1.minute-1) to aid
      analgesia and controlled hypotension with a mean arterial pressure not less than 60 mm Hg. An
      oropharyngeal pack was inserted for everyone and taken out gently before emergence and
      extubation. All patients received dexamethasone 8 mg, ondansetron 4 mg, 1 gram of paracetamol
      and 0.1 mg.kg-1 morphine intravenously. Morphine was given at the end of surgery by the time
      of turning the remifentanil infusion off. Midazolam or normal saline was randomly and blindly
      administered to patients using a 3 ml syringe (1mg.ml-1) at time of turning the remifentanil
      infusion off. By the end of surgery, desflurane was turned off and nobody received reversal
      for the cisatracurium, then smooth suctioning of the oral cavity was performed followed by
      awake extubation. No stimulation was used to aid patient's recovery except for gentle verbal
      commands.
    

Intervention name(s): Intravenous midazolam before emergence from general anesthesia; Intravenous normal saline before emergence from general anesthesia
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous administration of 0.03 mg/kg midazolam just before emergence from anesthesia.; Intravenous administration of normal saline just before emergence from anesthesia.
Other intervention name(s): Versed; Normal saline 0.9%
Intervention MeSH terms: Midazolam; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Agitation; Midazolam; Nasal surgery; Emergence