MedDataX Logo

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

NCT ID: NCT07302815

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-10

Study Completion Date

2026-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Emergence agitation (EA) is characterised by confusion, restlessness or aggressive behaviour during recovery from general anaesthesia. EA is more common following ear, nose, \& throat (ENT) surgery. The exact cause and pathophysiology of EA are unknown, although risk factors include preschool age, preoperative anxiety, postoperative pain, nausea, vomiting, otolaryngology operations, and the use of inhalational anesthetics particularly sevoflurane. EA might cause injury, accidental removal of intravenous cannulation, self-extubation, post-operative wound bleeding and increase the nursing requirements in the post-anesthesia care unit (PACU). There are limited studies concerning adult EA, and although its prevalence is less than child EA, it carries more risk of injury due to serious uncontrolled behaviors. Intravenous (IV) anesthetics, sedatives and opioids are the most frequently utilized medications to manage EA, with variable success rates and significant potential to delay recovery and cause undesirable side-effects. Dexmedetomidine is a highly selective α2 agonist which produces sedation and anxiolysis through reduction in sympathetic central nervous system activity. It has a major advantage over other sedatives; it is associated with minimal respiratory depression. According to a recent meta-analysis, intraoperative administration of dexmedetomidine decreases postoperative pain and the incidence of EA in adults. Considering the short length of corrective nasal reduction surgery (CR), an intraoperative infusion of dexmedetomidine as an anesthetic adjuvant may prolong the anesthesia and recovery time. Low dose infusion of dexmedetomidine (0.2 µg /kg/h) has been reported to reduce incidence of EA and opioid consumption effectively in elderly patients undergoing cancer surgeries under GA. Previous studies have shown that a single dose of dexmedetomidine, not as a premedication, is also effective in reducing EA and facilitating smooth extubation after pediatric adenotonsillectomy. Also recent study reported the efficacy of pre-operative dexmedetomidine administration (1 μg/kg) in preventing EA in adults undergoing CR of a nasal bone fracture. Up till now no clinical studies investigated the efficacy of single pre-operative micro dose of dexmedetomidine in prevention of EA, so in this clinical study we hypothesize that preoperative micro dose of dexmedetomidine may be beneficial in mitigation of EA in short timed Septoplasty surgeries safely and without prolongation of recovery time.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Emergence Agitation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Emergence agitation septoplasty surgeries micro-dose Dexmedetomidine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel assignment
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dexmedetomidine group

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.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Control group

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.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexmedetomidine

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

Intervention Type DRUG

Saline

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tanta University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mai Salah Salem

lecturer of anesthesia, surgical intensive care and pain management

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tanta university

Tanta, Gharbia Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mai Salah Salem, MD anesthesia, SIC

Role: CONTACT

Phone: +00201061107658

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 31391001 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16101707 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28949804 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39891093 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34660472 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 40095538 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12060332 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20526708 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33177329 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

36264PR131061/11/25

Identifier Type: -

Identifier Source: org_study_id