Preemptive Intravenous Micro-dose Dexmedetomidine to Prevent Emergence Agitation in Adult Patients Undergoing Septoplasty Surgeries

NCT07302815 | Active Not Recruiting

• 1 other identifier: 36264PR131061/11/25
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized controlled study will be conducted to evaluate the effect of preoperative single, micro-dose of dexmedetomidine (0.3μg/kg) on the incidence and severity of EA in adults undergoing Septoplasty surgeries

Conditions

Emergence Agitation

Keywords

Emergence agitation; septoplasty surgeries; micro-dose Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Incidence of emergence agitation

  using Aono's Four-Point Scale (Aono Scale) which is a simple and widely used tool to assess emergence agitation (EA). It categorizes agitation during emergence from anesthesia into four levels. 1. calm\_ Patient is quiet and not agitated. 2. Not calm but can be easily consoled \_ Slight restlessness but settles with verbal reassurance or mild physical comfort. 3. Moderately agitated \_ Patient is crying or difficult to console but not combative. 4. Severely agitated \_Patient is thrashing, inconsolable, or combative, and poses risk of injury to self or staff. Scores 3-4 indicate clinically relevant emergence agitation.

  incidence of emergence agitation will be assessed by Aono's Four-point Scale (AFPS) after extubation, at PACU arrival, every 5 minutes for the first 15 minutes then every 15 minutes for the first hour after surgery.

Secondary Outcomes (5)

• severity of emergence agitation

  severity of EA will be assessed by Aono's Four-point Scale (AFPS) after extubation, at PACU arrival, every 5 minutes for the first 15 minutes then every 15 minutes for the first hour after surgery.

• extubation time

  Extubation time is the duration between the cessation of anesthetic agents and removal of endotracheal tube (ETT).

• Length of stay in the post anesthetic care unit (PACU).

  time from the moment they arrive after surgery until they meet discharge criteria and are officially transferred to the ward

• Intraoperative opioid consumption

  from induction of anesthesia until completion of surgery

• Post operative numerical rating scale score (NRS)

  - NRS score is measured at PACU arrival and every 15 minutes for 1 hour after surgery

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

60 patients will receive preoperative micro dose of dexmedetomidine (0.3 µg /kg) in 50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery.

Drug: Dexmedetomidine

Control group

PLACEBO COMPARATOR

60 patients will receive preoperative micro dose of dexmedetomidine (0.3 µg /kg) in 50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery.

Drug: Saline

Interventions

Saline DRUG

50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery.

Control group

Dexmedetomidine DRUG

micro dose of dexmedetomidine (0.3 µg /kg) in 50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery.

Dexmedetomidine group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients of both gender aged 18 to 60 years with American Society of Anesthesiologists (ASA) Physical Status I or II, who were scheduled for septoplasty surgery under general anesthesia.

You may not qualify if:

• Patients declined to participate in the trial.
• History or clinical evidence of chronic obstructive pulmonary disease.
• History of renal or hepatic dysfunction, sleep apnea syndrome.
• Cognitive dysfunction or psychiatric disorder.
• Patients receiving beta blocker.
• Patients with anticipated difficult airway.
• Patients with electro cardiac abnormalities.
• Emergency surgeries.
• Pregnancy.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta university

Tanta, Gharbia Governorate, 31527, Egypt

Location

Related Publications (9)

• Kim JC, Kim J, Kwak H, Ahn SW. Premedication with dexmedetomidine to reduce emergence agitation: a randomized controlled trial. BMC Anesthesiol. 2019 Aug 7;19(1):144. doi: 10.1186/s12871-019-0816-5.

  PMID: 31391001 BACKGROUND

• Guler G, Akin A, Tosun Z, Ors S, Esmaoglu A, Boyaci A. Single-dose dexmedetomidine reduces agitation and provides smooth extubation after pediatric adenotonsillectomy. Paediatr Anaesth. 2005 Sep;15(9):762-6. doi: 10.1111/j.1460-9592.2004.01541.x.

  PMID: 16101707 BACKGROUND

• Lee HS, Yoon HY, Jin HJ, Hwang SH. Can Dexmedetomidine Influence Recovery Profiles from General Anesthesia in Nasal Surgery? Otolaryngol Head Neck Surg. 2018 Jan;158(1):43-53. doi: 10.1177/0194599817733735. Epub 2017 Sep 26.

  PMID: 28949804 BACKGROUND

• Abdelaziz TSA, Mohammed Elsayed HE, Kamal Eldin DM, Ibrahim IM. "The effect of intramuscular dexmedetomidine versus oral gabapentin premedication on the emergence agitation after rhinoplasty". A prospective, randomized, double-blind controlled trial. BMC Anesthesiol. 2025 Jan 31;25(1):50. doi: 10.1186/s12871-025-02914-5.

  PMID: 39891093 BACKGROUND

• Zhu W, Sun J, He J, Zhang W, Shi M. A Randomized Controlled Study of Caudal Dexmedetomidine for the Prevention of Postoperative Agitation in Children Undergoing Urethroplasty. Front Pediatr. 2021 Sep 29;9:658047. doi: 10.3389/fped.2021.658047. eCollection 2021.

  PMID: 34660472 BACKGROUND

• Al Mutair A, Alabbasi Y, Alshammari B, Alrasheeday AM, Alharbi HF, Aleid AM. A Meta-Analysis of the Impact of Intranasal Dexmedetomidine on Emergence Delirium and Agitation in Children and Adolescents Undergoing Tonsillectomy and/or Adenoidectomy. J Clin Med. 2025 Feb 26;14(5):1586. doi: 10.3390/jcm14051586.

  PMID: 40095538 BACKGROUND

• Cole JW, Murray DJ, McAllister JD, Hirshberg GE. Emergence behaviour in children: defining the incidence of excitement and agitation following anaesthesia. Paediatr Anaesth. 2002 Jun;12(5):442-7. doi: 10.1046/j.1460-9592.2002.00868.x.

  PMID: 12060332 BACKGROUND

• 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

• Tolly B, Waly A, Peterson G, Erbes CR, Prielipp RC, Apostolidou I. Adult Emergence Agitation: A Veteran-Focused Narrative Review. Anesth Analg. 2021 Feb 1;132(2):353-364. doi: 10.1213/ANE.0000000000005211.

  PMID: 33177329 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

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; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia, surgical intensive care and pain management

Model Details: parallel assignment

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: January 10, 2026
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: May 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available upon a reasonable request from the corresponding author after the end of the study for one year
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)