Intranasal Dexmedetomidine Premedication

NCT ID: NCT02108171

Last Updated: 2016-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-07-31

Brief Summary

Most patients with preoperative varying degrees of stress, anxiety, which makes the stress response in patients and affect the normal conduct of anesthesia and surgery.The sympathetic system hyperexcitability prone to cause adverse cardiovascular events and affect postoperative recovery. However, phenobarbital, as the traditional premedication, has less sedative, weak anxiolytic and other shortcomings. Midazolam accompanied by inhibition of respiration,excessive sedation, easily induced delirium,prolonged recovery time and so on. Dexmedetomidine is a highly selective α2-adrenergic receptor agonist, it has sedative, anxiolytic, no inhibition of respiration, and also colorless, odorless, non-mucosal stimulation, nasal drip ease of administration, patient acceptance, comfortable. Therefore, dexmedetomidine as premedication has certain advantages. The purpose of this research is to study sedative effect, safety and the impact of anesthesia recovery period of intranasal dexmedetomidine premedication for suspension laryngoscopy.

Detailed Description

All patients received intranasal dexmedetomidine (1μg.kg-1) or placebo at approximately 45 min before induction of anesthesia.The study drug was prepared in a 1-ml syringe.An equal volume of dexmedetomidine or placebo was dropped into each nostril by a blinded research assistant in the supine position.Automatic sphygmomanometer measure blood pressure.Oxygen saturation and heart rate were measured by a pulse oximeter. Respiratory rate, sedation score and anxiety levels regularly assessed. Patients with general anesthesia, suspension laryngoscopy surgery and postoperative care, standard monitoring are unified.

Conditions

Benign Neoplasm of Vocal Fold - Glottis

Study Design

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

Study Groups

dexmedetomidine

intranasal dexmedetomidine

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia.

placebo

intranasal saline

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia.

Interventions

Dexmedetomidine

intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia.

Intervention Type: DRUG

placebo

0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia.

Intervention Type: DRUG

Other Intervention Names

intranasal dexmedetomidine; saline

Eligibility Criteria

Inclusion Criteria

• Surgery:The laryngoscope vocal polyp excision
• Aged 18 to 60 years old
• Body mass index (BMI) < 30 kg/m2
• American society of Anesthesiologist (ASA) I -II

Exclusion Criteria

• The investigator refused to participate
• Known allergy or hypersensitive reaction to dexmedetomidine or anesthetic
• With previous history of heart disease
• Pregnant women; no reliable contraceptive measures in postmenopausal women
• Preoperative heart rate less than 45bpm; Ⅱ or Ⅲ degree atrioventricular block; ischemic heart disease
• Taking antihypertensive drugs such as methyldopa, clonidine and other α2 receptor agonist
• Asthma
• Sleep apnea syndrome
• Liver and kidney dysfunction
• Known to suffer from mental illness
• Long-term use of sedatives and analgesics in patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou First People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain

Vice Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiangcai Ruan, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Guangzhou First Municipal People's Hospital,Guangzhou Medical College

Locations

Guangzhou First Municipal People's Hospital

Guangzhou, Guangdong, China

Guangzhou First Municipal People's Hospital

Guangzhou, , China

Countries

China

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 20645951 (View on PubMed)

Lu C, Zhang LM, Zhang Y, Ying Y, Li L, Xu L, Ruan X. Intranasal Dexmedetomidine as a Sedative Premedication for Patients Undergoing Suspension Laryngoscopy: A Randomized Double-Blind Study. PLoS One. 2016 May 19;11(5):e0154192. doi: 10.1371/journal.pone.0154192. eCollection 2016.

Reference Type: DERIVED

PMID: 27196121 (View on PubMed)

Other Identifiers

GZFPH-IRB-2013-086

Identifier Type: -

Identifier Source: org_study_id