Dexmedetomidine in Reducing Incidence of Emergence Agitation After Nasal Surgery

NCT ID: NCT05634148

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-22
• Study Completion Date: 2023-04-01

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.

Conditions

Postoperative Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Dexmedetomidine group

Patients in this group will receive intravenous dexmedetomidine before extubation

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Intravenous dexmedetomidine will be administered 45 minutes before extubation in intervention group

Control group

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

Group Type: PLACEBO_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

Intravenous dexmedetomidine will be administered 45 minutes before extubation in intervention group

Interventions

Dexmedetomidine

Intravenous dexmedetomidine will be administered 45 minutes before extubation in intervention group

Intervention Type: DRUG

Other Intervention Names

Control

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Security Forces Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anwar ul Huda

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anwar Huda, FRCA

Role: PRINCIPAL_INVESTIGATOR

Security Forces Hospital

Locations

Security Forces Hospital

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

SFH-Dex Nasal

Identifier Type: -

Identifier Source: org_study_id