Effect of Dexmedetomidine After Thyroidectomy

Chosun University Hospital

Status: Completed

Conditions: Thyroid Tumor

Treatments: Other: Time to remove drainage and duration of hospital staying; Other: Postoperative bleeding; Behavioral: Cough reflex; Behavioral: Visual analogue scale; Drug: Desflurane; Drug: Remifentanil; Other: Postoperative complications; Behavioral: Ramsay Sedation Scale; Drug: Dexmedetomidine; Drug: Normal saline; Other: Extubation time and Recovery time; Procedure: Thyroidectomy; Other: Vital signs

Study type: Interventional

Funder types: Other

Identifiers

NCT02412150

2014-04-004-003 (Other Identifier)

DEX_ENT

Details and patient eligibility

About

The purpose of the present study was to compare the effect of dexmedetomidine which is administered during emergence in adult patients undergoing elective thyroidectomy on smooth emergence form general anesthesia (reducing agitation or coughing, signs of hypertension or tachycardia, or etc.) and postoperative outcome (postoperative bleeding and hospital staying).

Full description

Smooth emergence from general anaesthesia after surgery is important to prevent potentially dangerous effects such as hypertension, tachycardia, myocardial ischaemia, arrhythmias and increased intracranial and intra-abdominal pressure. After thyroidectomy, activities during emergence such as agitation or coughing, signs of hypertension or tachycardia, or etc. may lead to postoperative bleeding, resulting in acute airway obstruction or reoperation.

The purpose of the present study was to compare the effect of dexmedetomidine which is administered during emergence in adult patients undergoing elective thyroidectomy on smooth emergence form general anesthesia and postoperative outcome.

Enrollment: 139 patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patient,
• Aged 20-60 yr,
• ASA physical status 1-2,
• Patients undergoing elective thyroidectomy under general anesthesia

Exclusion criteria

• Sighs of difficult airway,
• History of respiratory disease or chronic cough,
• Cardiovascular disease,
• Pregnant or breast-feeding woman

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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139 participants in 2 patient groups, including a placebo group

Dexmedetomidine (Group D)

Experimental group

Description:

After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.

Treatment:

Other: Extubation time and Recovery time

Behavioral: Cough reflex

Other: Vital signs

Procedure: Thyroidectomy

Other: Postoperative complications

Drug: Dexmedetomidine

Other: Time to remove drainage and duration of hospital staying

Drug: Remifentanil

Behavioral: Visual analogue scale

Drug: Desflurane

Other: Postoperative bleeding

Behavioral: Ramsay Sedation Scale

Normal Saline (Group N)

Placebo Comparator group

Description:

After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.

Treatment:

Other: Extubation time and Recovery time

Behavioral: Cough reflex

Other: Vital signs

Procedure: Thyroidectomy

Drug: Normal saline

Other: Postoperative complications

Other: Time to remove drainage and duration of hospital staying

Drug: Remifentanil

Behavioral: Visual analogue scale

Drug: Desflurane

Other: Postoperative bleeding

Behavioral: Ramsay Sedation Scale