Dexmedetomidine and Agitation After Nasal Surgery

NCT06867302 | Recruiting

• 1 other identifier: R656
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of study is to compare dexmedetomidine single bolus dose before extubation with continuous infusion as regards their efficacy in mitigating the incidence of emergence agitation in obese adults undergoing nasal surgery.

Conditions

Nasal Disease; Agitation, Emergence

Keywords

Dexmedetomidine; Emergence agitation; Nasal surgery

Outcome Measures

Primary Outcomes (1)

• Degree of emergence agitation by Richmond Agitation Sedation Scale (RASS)

  RASS is a 10-point scoring system used to assess patient's level of agitation and sedation: 4 levels for agitation, 1 level for normal (alert and calm), and 5 levels of sedation

  5 minutes after operation

Secondary Outcomes (13)

• Intraoperative heart rate

  Every 15 minutes along operation

• Intraoperative mean arterial blood pressure

  Every 15 minutes along operation

• Time of first rescue analgesic

  5 minutes before first analgesic request

• Extubation time

  3 minutes after removal of endotracheal tube

• Postanesthesia care unit time

  5 minutes after discharge from recovery unit

Other Outcomes (5)

• Age

  5 minutes before entering operation department

• Sex

  5 minutes before entering operation department

• Weight

  5 minutes before entering operation department

Study Arms (2)

Bolus group

EXPERIMENTAL

single dose 0.5 µg/kg in 15 ml saline over 10 min , started 15 minutes before end of surgery

Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)

Infusion group

EXPERIMENTAL

Infusion of dexmedetomidine at a dose of 0.5 µg/kg/h without loading dose all through intraoperative time

Drug: Dexmedetomidine Injection [Precedex]

Interventions

Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) DRUG

An infusion given all through intraoperative time

Also known as: Dexmedetomidine infusion

Bolus group

Dexmedetomidine Injection [Precedex] DRUG

Single dose given 15 minutes before end of surgery

Also known as: Dexmedetomidine bolus

Infusion group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologist (ASA) Ⅰ or II
• Adults with body mass index (BMI) \< 30 Kg/m
• Underwent elective nasal surgery.

You may not qualify if:

• Significant comorbidity like hepatic, renal, or cardiac disease
• Auditory impairment
• Cognitive dysfunction
• Substance abuse
• Allergy to the studied medicines
• Planned intensive care admission after the surgery.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University Hospital

Al Fayyum, Faiyum Governorate, 63514, Egypt

RECRUITING

Related Publications (5)

• Yu D, Chai W, Sun X, Yao L. Emergence agitation in adults: risk factors in 2,000 patients. Can J Anaesth. 2010 Sep;57(9):843-8. doi: 10.1007/s12630-010-9338-9. Epub 2010 Jun 5.

  PMID: 20526708 BACKGROUND

• Hudek K. Emergence delirium: a nursing perspective. AORN J. 2009 Mar;89(3):509-16; quiz 517-9. doi: 10.1016/j.aorn.2008.12.026.

  PMID: 19326585 BACKGROUND

• Kim HJ, Kim DK, Kim HY, Kim JK, Choi SW. Risk factors of emergence agitation in adults undergoing general anesthesia for nasal surgery. Clin Exp Otorhinolaryngol. 2015 Mar;8(1):46-51. doi: 10.3342/ceo.2015.8.1.46. Epub 2015 Feb 3.

  PMID: 25729495 BACKGROUND

• Lepouse C, Lautner CA, Liu L, Gomis P, Leon A. Emergence delirium in adults in the post-anaesthesia care unit. Br J Anaesth. 2006 Jun;96(6):747-53. doi: 10.1093/bja/ael094. Epub 2006 May 2.

  PMID: 16670111 BACKGROUND

• Zhu M, Wang H, Zhu A, Niu K, Wang G. Meta-analysis of dexmedetomidine on emergence agitation and recovery profiles in children after sevoflurane anesthesia: different administration and different dosage. PLoS One. 2015 Apr 13;10(4):e0123728. doi: 10.1371/journal.pone.0123728. eCollection 2015.

  PMID: 25874562 BACKGROUND

MeSH Terms

Conditions

Nose Diseases; Emergence Delirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yasser S Mostafa, MD

  Fayoum University

  PRINCIPAL INVESTIGATOR

• Mohamed A Shawky, MD

  Fayoum University

  STUDY CHAIR

Central Study Contacts

Yasser S Mostafa, MD

CONTACT

01010509735; ysm03@fayoum.edu.eg

Mohamed A Shawky, MD

CONTACT

0 109 525 4547; mas14@fayoum.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Apart from the anesthesiologists who performed the blocks, all patients, surgeons, and postoperative nurses remained blinded to randomization throughout the study period.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology

Model Details: the patients will be randomly allocated into two groups based on a computerized randomization table created by a researcher who was not involved in the study. The researcher assigned a random ID to each patient, and a blinded anesthesiologist used this ID while collecting the postoperative data in the surgical ward.

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: March 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)