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Dexmedetomidine in Reducing Incidence of Emergence Agitation After Nasal Surgery

Primary Purpose

Postoperative Delirium

Status
Completed
Phase
Phase 3
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
Security Forces Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Delirium

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: We will include patients aged 15 years to 65 years, ASA 1-3 who are planned to undergo general anesthesia for elective nasal surgeries in which nasal packing is used postoperatively Exclusion Criteria: We will exclude patients with known allergy to study medications, BMI more than 35, history of obstructive sleep apnea, history of psychiatric illness, pregnancy and presence of liver and renal diseases.

Sites / Locations

  • Security Forces Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexmedetomidine group

Control group

Arm Description

Patients in this group will receive intravenous dexmedetomidine before extubation

Patients in this group will receive intravenous placebo (0.9 % saline) before extubation

Outcomes

Primary Outcome Measures

Riker sedation-agitation score
Assessment of emergence delirium after extubation. It has numbers from 1-7.

Secondary Outcome Measures

Postoperative pain score
Numerical rating scale pain score in PACU. from 0 to 10 with 10 worst pain
Opioid consumption
Morphine equivalent consumption in PACU
Adverse events
Intraoperative or postoperative adverse events
Duration of stay in PACU
duration of PACU stay

Full Information

First Posted
November 21, 2022
Last Updated
April 1, 2023
Sponsor
Security Forces Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05634148
Brief Title
Dexmedetomidine in Reducing Incidence of Emergence Agitation After Nasal Surgery
Official Title
Effect of a Single Dose Infusion of Dexmedetomidine in Reducing Incidence of Emergence Agitation After Nasal Surgery - a Randomised Contolled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 22, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Security Forces Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Various pharmacological interventions have been attempted previously to prevent postoperative EA with variable results. These include use of opioids, propofol, midazolam, ketamine, magnesium and alpha-2 agonists like clonidine and dexmedetomidine. Dexmedetomidine have been used with different dosages and different timings of administration with variable results and at the expense of major hemodynamic disturbances. The objective of this study was to investigate the role of single dose of dexmedetomidine (0.5 mcg/kg) administered as 30 minutes infusion prior to extubation in reducing the incidence and severity of EA and coughing on extubation.
Detailed Description
Emergence agitation (EA) or delirium is a post anesthesia complication which is manifested as confusion, agitation, disorientation and aggressive behavior. It can lead to serious consequences including hemorrhage, removal of lines, drains and catheters, self-extubation and even falling out of bed resulting in severe injuries. EA is associated with cognitive deficit, physical dependence, increased hospital stay and higher mortality. There is wide variation in the incidence of EA in scientific literature ranging from 5 % to 27.3 %. There are no clear diagnostic criteria for EA because of its varied clinical manifestations. Although many risk factors have been identified including pain, presence of stress at the time of induction, induction with etomidate, use of premedication with benzodiazepines, hypoxemia, type of surgery, awakening in hostile and noisy environment and presence of urinary catheter. Patients undergoing nasal surgeries are in particular, at higher risk for EA due to a sense of suffocation secondary to nasal packing. Various pharmacological interventions have been attempted previously to prevent postoperative EA with variable results. These include use of opioids, propofol, midazolam, ketamine, magnesium and alpha-2 agonists like clonidine and dexmedetomidine. Dexmedetomidine have been used with different dosages and different timings of administration with variable results and at the expense of major hemodynamic disturbances. The objective of this study was to investigate the role of single dose of dexmedetomidine (0.5 mcg/kg) administered as 30 minutes infusion prior to extubation in reducing the incidence and severity of EA and coughing on extubation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine group
Arm Type
Experimental
Arm Description
Patients in this group will receive intravenous dexmedetomidine before extubation
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients in this group will receive intravenous placebo (0.9 % saline) before extubation
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Control
Intervention Description
Intravenous dexmedetomidine will be administered 45 minutes before extubation in intervention group
Primary Outcome Measure Information:
Title
Riker sedation-agitation score
Description
Assessment of emergence delirium after extubation. It has numbers from 1-7.
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Postoperative pain score
Description
Numerical rating scale pain score in PACU. from 0 to 10 with 10 worst pain
Time Frame
60 minutes
Title
Opioid consumption
Description
Morphine equivalent consumption in PACU
Time Frame
60 minutes
Title
Adverse events
Description
Intraoperative or postoperative adverse events
Time Frame
60 minutes
Title
Duration of stay in PACU
Description
duration of PACU stay
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: We will include patients aged 15 years to 65 years, ASA 1-3 who are planned to undergo general anesthesia for elective nasal surgeries in which nasal packing is used postoperatively Exclusion Criteria: We will exclude patients with known allergy to study medications, BMI more than 35, history of obstructive sleep apnea, history of psychiatric illness, pregnancy and presence of liver and renal diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anwar Huda, FRCA
Organizational Affiliation
Security Forces Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Security Forces Hospital
City
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Dexmedetomidine in Reducing Incidence of Emergence Agitation After Nasal Surgery

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