Dexmedetomidine Combined With Hydromorphone in Tonsillectomy and Adenoidectomy

NCT ID: NCT03760809

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-04
• Study Completion Date: 2019-04-01

Brief Summary

Tonsillectomy and adenoidectomy is one of the most common pediatric surgeries, and agitation and severe postoperative pain have been considered a very common complications. Dexmedetomidine mainly inhibits the release of norepinephrine by acting on the α-adrenergic receptor of the brainstem nucleus, which can produce good sedative effects. Hydromorphone has a longer duration of action than fentanyl, and it also has a certain sedative effect. The combination of the two is more conducive to the management of postanesthetic agitation and pain. This study was to compare the effect of different doses of dexmedetomidine combined with hydromorphone in the sedation and analgesia after pediatric tonsillectomy and adenoidectomy.

Detailed Description

The computer generates random numbers to allocate patients into different group. Trained research staff who are not involved in the study collect the data. The observer who only stayed in PACU was blinded to the allocation and responsible to record the data.

The primary measurement are pain scores, PAED scores, coughing was evaluated on a 9-point scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4 times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times, 9= laryngospasm), and extubation time. The secondary measurements are the time to discharge from the post-anaesthesia care unit, and the number of postoperative desaturation.

A sample size of 57 was determined by analysis based on the assumption of the decline of extubation time from other similar study and α=0.05,β=0.2.

The continuous variables were presented as means ± SD and the categorical variables were expressed as frequency.

The outcome of interest is extubation time decline.

Conditions

Agitated; State, Acute Reaction to Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

group A

Dexmedetomidine(0.5 μg／kg)/hydromophine-based general anesthesia

Group Type: EXPERIMENTAL

Dexmedetomidine 0.5μg／kg

Intervention Type: DRUG

Group A received dexmedetomidine 0.5μg／kg (diluted to 100ml，influded in 5 mins at the beginning of the surgery) and hydromophine 0.03 mg／kg as a bolus.

group B

Dexmedetomidine(1μg／kg)/hydromophine-based general anesthesia

Group Type: EXPERIMENTAL

Dexmedetomidine 1μg／kg

Intervention Type: DRUG

Group B received dexmedetomidine 1μg／kg (diluted to 100ml，influded in 5 mins at the beginning of the surgery) and hydromophine 0.03 mg／kg as a bolus.

Interventions

Dexmedetomidine 0.5μg／kg

Group A received dexmedetomidine 0.5μg／kg (diluted to 100ml，influded in 5 mins at the beginning of the surgery) and hydromophine 0.03 mg／kg as a bolus.

Intervention Type: DRUG

Dexmedetomidine 1μg／kg

Group B received dexmedetomidine 1μg／kg (diluted to 100ml，influded in 5 mins at the beginning of the surgery) and hydromophine 0.03 mg／kg as a bolus.

Intervention Type: DRUG

Other Intervention Names

Dexmedetomidine Hydrochloride Injection; Dexmedetomidine Hydrochloride Injection

Eligibility Criteria

Inclusion Criteria

• experienced tonsillectomy and adenoidectomy
• ASA physical status I-II
• weight 12-30 kg

Exclusion Criteria

• respiratory disease
• circulatory or nervous system disease
• hepatic dysfunction
• known adverse reactions to hydromophine and dexmedetomidine

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

e ji Jia, M.D.

Role: PRINCIPAL_INVESTIGATOR

Eye and ENT Hospital of Fudan University

Locations

Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

References

Olutoye OA, Glover CD, Diefenderfer JW, McGilberry M, Wyatt MM, Larrier DR, Friedman EM, Watcha MF. The effect of intraoperative dexmedetomidine on postoperative analgesia and sedation in pediatric patients undergoing tonsillectomy and adenoidectomy. Anesth Analg. 2010 Aug;111(2):490-5. doi: 10.1213/ANE.0b013e3181e33429. Epub 2010 Jul 7.

Reference Type: BACKGROUND

PMID: 20610555 (View on PubMed)

Brown KA. What we don't know about childhood obstructive sleep apnoea. Paediatr Anaesth. 2001 Jul;11(4):385-9. doi: 10.1046/j.1460-9592.2001.00719.x. No abstract available.

Reference Type: RESULT

PMID: 11442853 (View on PubMed)

Patel A, Davidson M, Tran MC, Quraishi H, Schoenberg C, Sant M, Lin A, Sun X. Dexmedetomidine infusion for analgesia and prevention of emergence agitation in children with obstructive sleep apnea syndrome undergoing tonsillectomy and adenoidectomy. Anesth Analg. 2010 Oct;111(4):1004-10. doi: 10.1213/ANE.0b013e3181ee82fa. Epub 2010 Aug 12.

Reference Type: RESULT

PMID: 20705788 (View on PubMed)

Hauber JA, Davis PJ, Bendel LP, Martyn SV, McCarthy DL, Evans MC, Cladis FP, Cunningham S, Lang RS, Campbell NF, Tuchman JB, Young MC. Dexmedetomidine as a Rapid Bolus for Treatment and Prophylactic Prevention of Emergence Agitation in Anesthetized Children. Anesth Analg. 2015 Nov;121(5):1308-15. doi: 10.1213/ANE.0000000000000931.

Reference Type: RESULT

PMID: 26332857 (View on PubMed)

Yi W, Li J, Zhuang Y, Wan L, Li W, Jia J. The effect of two different doses of dexmedetomidine to prevent emergence agitation in children undergoing adenotonsillectomy: a randomized controlled trial. Braz J Anesthesiol. 2022 Jan-Feb;72(1):63-68. doi: 10.1016/j.bjane.2021.08.019. Epub 2021 Oct 8.

Reference Type: DERIVED

PMID: 34627829 (View on PubMed)

Other Identifiers

dex-hyd

Identifier Type: -

Identifier Source: org_study_id