Midazolam Effect on Agitation Postnasal Surgery

NCT05165914 | Completed

• 1 other identifier: JordanianRoyalMS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Agitation

Keywords

Agitation; Midazolam; Nasal surgery; Emergence

Outcome Measures

Primary Outcomes (1)

• Development of agitation

  Agitation is diagnosed using the maximum score of Richmond Agitation Sedation Scale (RASS)

  Up to one hour after extubation

Study Arms (2)

Midazolam group

ACTIVE COMPARATOR

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

Intravenous midazolam before emergence from general anesthesia DRUG

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

Also known as: Versed

Midazolam group

Intravenous normal saline before emergence from general anesthesia DRUG

Intravenous administration of normal saline just before emergence from anesthesia.

Also known as: Normal saline 0.9%

Placebo group

Eligibility Criteria

• Age: 16 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• ASA grade more than 2.
• Age less than 16 or more than 59 years.
• Any surgery that doesn't involve the nose or sinuses.

Sponsors & Collaborators

• Jordanian Royal Medical Services: lead

Study Sites (1)

Royal Medical Services

Amman, 11855, Jordan

Location

Related Publications (4)

• Kim SY, Kim JM, Lee JH, Song BM, Koo BN. Efficacy of intraoperative dexmedetomidine infusion on emergence agitation and quality of recovery after nasal surgery. Br J Anaesth. 2013 Aug;111(2):222-8. doi: 10.1093/bja/aet056. Epub 2013 Mar 22.

  PMID: 23524149 RESULT

• Kim KM, Lee KH, Kim YH, Ko MJ, Jung JW, Kang E. Comparison of effects of intravenous midazolam and ketamine on emergence agitation in children: Randomized controlled trial. J Int Med Res. 2016 Apr;44(2):258-66. doi: 10.1177/0300060515621639. Epub 2016 Feb 15.

  PMID: 26880794 RESULT

• Cho EJ, Yoon SZ, Cho JE, Lee HW. Comparison of the effects of 0.03 and 0.05 mg/kg midazolam with placebo on prevention of emergence agitation in children having strabismus surgery. Anesthesiology. 2014 Jun;120(6):1354-61. doi: 10.1097/ALN.0000000000000181.

  PMID: 24566243 RESULT

• Sherwin TS, Green SM, Khan A, Chapman DS, Dannenberg B. Does adjunctive midazolam reduce recovery agitation after ketamine sedation for pediatric procedures? A randomized, double-blind, placebo-controlled trial. Ann Emerg Med. 2000 Mar;35(3):229-38. doi: 10.1016/s0196-0644(00)70073-4.

  PMID: 10692189 RESULT

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Midazolam; Saline Solution

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ahmad Ben Tareef, MD

  Jordanian Royal Medical Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 21, 2021
• Study Start: May 27, 2021
• Primary Completion: November 25, 2021
• Study Completion: December 1, 2021
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)