Midazolam Effect on Agitation Postnasal Surgery

Sponsor

Jordanian Royal Medical Services (Other)

Overall Status

Completed

CT.gov ID

NCT05165914

Collaborator

(none)

100

Enrollment

Location

Arms

6.2

Actual Duration (Months)

16.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Agitation	Drug: Intravenous midazolam before emergence from general anesthesia Drug: Intravenous normal saline before emergence from general anesthesia	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Midazolam Effect on Agitation Postnasal Surgery: A Double Blinded Randomized Controlled Trial

Actual Study Start Date :

May 27, 2021

Actual Primary Completion Date :

Nov 25, 2021

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Midazolam group In the midazolam group, patients double blindly received 0.03 mg.kg-1 midazolam intravenously just before emergence from general anesthesia.	Drug: Intravenous midazolam before emergence from general anesthesia Intravenous administration of 0.03 mg/kg midazolam just before emergence from anesthesia. Other Names: Versed
Placebo Comparator: Placebo group In the placebo group, patients double blindly received normal saline of similar volume to midazolam just before emergence from general anesthesia.	Drug: Intravenous normal saline before emergence from general anesthesia Intravenous administration of normal saline just before emergence from anesthesia. Other Names: Normal saline 0.9%

Arm

Intervention/Treatment

Active Comparator: Midazolam group

In the midazolam group, patients double blindly received 0.03 mg.kg-1 midazolam intravenously just before emergence from general anesthesia.

Drug: Intravenous midazolam before emergence from general anesthesia

Intravenous administration of 0.03 mg/kg midazolam just before emergence from anesthesia.

Other Names:

Versed

Placebo Comparator: Placebo group

In the placebo group, patients double blindly received normal saline of similar volume to midazolam just before emergence from general anesthesia.

Drug: Intravenous normal saline before emergence from general anesthesia

Intravenous administration of normal saline just before emergence from anesthesia.

Other Names:

Normal saline 0.9%

Outcome Measures

Primary Outcome Measures

Development of agitation [Up to one hour after extubation]
Agitation is diagnosed using the maximum score of Richmond Agitation Sedation Scale (RASS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

American Society of Anesthesiologists (ASA) of either grade 1 or 2.
Age from 16 to 59 years.
Patients undergoing nasal surgery such as; septoplasty (SP), open septo-rhinoplasty (OSRP) and functional endoscopic sinus surgery (FESS).