Anticholinergic Premedication for Sedation With Dexmedetomidine During Spinal Anesthesia

Phase 4

Completed

• Conditions: Bradycardia
• Interventions: Drug: Atropine; Drug: Dexmedetomidine; Drug: Ephedrine

• Registration Number: NCT02522858
• Lead Sponsor: Sira Bang

Brief Summary

Dexmedetomidine is a selective α2 adrenergic receptor antagonist, which has little effect on respiratory suppression used as sedative agent. Also, dexmedetomidine has been reported to prolong the anesthesia time when used with patients undergoing spinal anesthesia. However, dexmedetomidine has sympathetic effect which can cause hypotension and bradycardia dose dependently. Therefore, this study is aimed to evaluate the effectiveness of premedication of anticholinergic agents on vital sign in patients undergoing spinal anesthesia.

Detailed Description

Before entering the operation room, patients are randomized in one group (A or C). For sedative premedication, all patients will be injected intramuscularly with midazolam 1mg. After entering the operation room, all patients will be monitored blood pressure, ECG and oxygen saturation. Before induction of spinal anesthesia, all patients will be loaded with plasma solution 5mL/kg. After induction of spinal anesthesia, block level will be checked. After fixation of block level, the loading dose(0.6ug/kg) of dexmedetomidine which is diluted with normal saline as 4ug/mL would be started for 10 minutes. However, just before starting dexmedetomidine,atropine .01\~0.03mg/kg up to 0.5mg would be injected in group A. Otherwise normal saline 0.5mL would be injected in group C. The syringed would be blinding not to be noticed. After loading of dexmedetomidine, the diluted solution would be injected with 0.25ug/kg/hr until the end of the surgery. Every patients undergoing sedation would be applied the oxygen by nasal prong.

The heart rate decreasing 30% from initial heart rate or under 40/min would be regarded as bradycardia needing treatment, and atropine 0.5mg will be injected intravenously. Systolic blood pressure decreasing 30% from basal blood pressure or under 90 mm Hg would be regarded as hypotension needing treatment, and ephedrine 5mg will be injected intravenously. The number of medication treated would be noted.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-05
• Study First Submitted QC: 2015-08-12
• Study First Posted: 2015-08-13
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-14
• Last Update Posted: 2016-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients who undergoing spinal anesthesia with sedation over 19 years old.

Read More

Exclusion Criteria

• Patients who are contraindicated of spinal anesthesia such as hypovolemic status, coagulation disorder, infection of tapping site, pregnancy, heart problem, history of drug allergy, drug abuser, anemia, headache and medication of antipsychotic drugs.
• Patiensts who are contraindicated of atropine such as glaucoma, voiding difficulty due to prostate hyperplasia, heart disease, ulcerative colitis, hyperthyroidism and fever.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atropine	Dexmedetomidine	After fixation of the block level of spinal anesthesia, and just before starting dexmedetomidine, ,atropine 0.03mg/kg would be injected intravenously.
Placebo	Dexmedetomidine	After fixation of the block level of spinal anesthesia, and just before starting dexmedetomidine, normal saline 0.5mL would be injected intravenously.
Placebo	Ephedrine	After fixation of the block level of spinal anesthesia, and just before starting dexmedetomidine, normal saline 0.5mL would be injected intravenously.
Atropine	Atropine	After fixation of the block level of spinal anesthesia, and just before starting dexmedetomidine, ,atropine 0.03mg/kg would be injected intravenously.
Atropine	Ephedrine	After fixation of the block level of spinal anesthesia, and just before starting dexmedetomidine, ,atropine 0.03mg/kg would be injected intravenously.

Primary Outcome Measures

Name	Time	Method
The incidence of bradycardia	30miniutes from starting dexmedetomidine with loading dose	The heart rate decreasing 30% from initial heart rate or under 40/min would be regarded as bradycardia needing treatment, and atropine 0.5mg will be injected intravenously.

Secondary Outcome Measures

Name	Time	Method
The incidence of hypotension	30miniutes from starting dexmedetomidine with loading dose	Systolic blood pressure decreasing 30% from basal blood pressure or under 90 mm Hg would be regarded as hypotension needing treatment, and ephedrine 5mg will be injected intravenously.

Trial Locations

Locations (1)

Inje University Seoul Paik Hospital, Seoul, Korea; 🇰🇷 Seoul, Jung-Gu,, Korea, Republic of