Midazolam Effect on Agitation Postnasal Surgery

December 17, 2021 updated by: Ahmad Ben Tareef, Jordanian Royal Medical Services

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan, 11855
        • Royal Medical Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 59 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of agitation
Time Frame: Up to one hour after extubation
Agitation is diagnosed using the maximum score of Richmond Agitation Sedation Scale (RASS)
Up to one hour after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordanian Royal Medical Services

Investigators

  • Principal Investigator: Ahmad Ben Tareef, MD, Jordanian Royal Medical Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2021

Primary Completion (Actual)

November 25, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

December 3, 2021

First Submitted That Met QC Criteria

December 17, 2021

First Posted (Actual)

December 21, 2021

Study Record Updates

Last Update Posted (Actual)

December 21, 2021

Last Update Submitted That Met QC Criteria

December 17, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JordanianRoyalMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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