Surgery Clinical Trial
Official title:
Randomized, Parallelled and Double-blinded Trial of Small-dose Dexmedetomidine Effects on Recovery Profiles of Supratentorial Tumors Patients From General Anesthesia
An excellent recovery profile is critical for neurosurgical anesthesia. Rapid awakening, smooth blood pressure and heart rate (HR), a higher degree of coordination, painless or mild pain, as well as better tolerance to endotracheal intubation can avoid can increased intracranial pressure, elevated blood pressure and rapid HR caused by emergency choking, suffocation and agitation, and can reduce postoperative cerebral edema and the risk of bleeding. In addition, it is easy for surgeons to timely evaluate postoperative patients' neurologic function based on the excellent recovery from anesthesia. Up to now, there are many methods and drugs to improve the quality of recovery period, but each of them has some flaws. Dexmedetomidine, an emerging anesthetic adjuvant, exhibits a stable hemodynamic recovery period, and cannot affect evaluation of neurological function with both the sedative and analgesic effects. We propose the following hypotheses: (1) A small dose of dexmedetomidine can be intravenously injected into patients subjected to craniotomy under general anesthesia, in order to improve the recovery profiles and reduce the incidence of emergence agitation. (2) Dexmedetomidine can reduce postoperative pain.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 35 Years to 65 Years |
Eligibility |
Inclusion Criteria: - American society of anesthesiologist class (ASA) I & II (ASA I: normal healthy patient; ASA II: patient with mild systemic disease; no functional limitation);Preoperative MRI diagnosis of supratentorial lesions (glioma, meningioma or neurofibroma), and tumor diameter <= 40 mm;The subject gets full score for Glasgow Coma Score;Estimated operation time <= 6 hours and anesthesia time <= 8 hours;The subject has given written informed consent. Exclusion Criteria: - The subject has participated in other clinical trials at 4 weeks before the beginning of the present study;The subject is taking or has taken ß-blockers (such as metoprolol) within 2 weeks before the beginning of the present study;The subject has undergone craniotomy twice or more;The subject has a history of sinus bradycardia (preoperative electrocardiogram of HR <= 50 beats/min), sick sinus syndrome, myocardial infarction, ? grade and grade ? cardiac function, and severe hypertension (systolic blood pressure (SBP)> = 180 mmHg or diastolic blood pressure (DBP)> = 110 mmHg);The subject has a history of lung disease (blood oxygen content <95% when breathing air at an awake state);The subject has a history of liver dysfunction (1.5 times or more that of the normal value);The subject has a history of kidney dysfunction (levels of serum creatinine and blood urea nitrogen are out of the normal range);Hypersensitivity to dexmedetomidine;Tolerance to dexmedetomidine;The subject has a history of drugs or alcohol abuse;The weight exceeds ±15% of standard weight range, and the standard weight is calculated as the following formula: standard weight=body height (cm)-100;Pregnant or lactating women;The subject is considered unsuitable for this trial. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Yue Yun | Shenyang | Liaoning |
Lead Sponsor | Collaborator |
---|---|
China Medical University, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hemodynamic impacts | Patients' SBP, DBP, MAP and HR are recorded before and every 5 minutes after drug intervention until recovery from anesthesia and removal of the tracheal intubation. Record SBP, DBP, MAP, HR, and SpO2 values immediately after extubation. Record SBP, DBP, MAP, HR, and SpO2 values every 5 minutes after extubation. Record SBP, DBP, MAP, HR, and SpO2 values every 5 minutes after PACU entry. Record SBP, DBP, MAP, HR, and SpO2 values at 0, 60, 120 and 240 minutes after returning to the ward. |
Up to 240 minutes after returning to the ward | No |
Secondary | Time of recovery from anesthesia | Record the patient's anesthesia time (from the anesthetic induction to termination of anesthetic infusion), operative time (from skin incision to the end of suturing), awakening time (from the end of surgery to eye opening in response to voices), spontaneous breathing recovery time (from the end of surgery to recovery of spontaneous breathing), extubation time (from the end of surgery to extubation). | From the anesthetic induction to extubation | No |
Secondary | Cough assessment at tracheal extubation | Using Four-point subjective scale: 0 = no cough; 1 = mild cough; 2 = moderate cough; 3 = severe cough. | At tracheal extubation | No |
Secondary | Degree of sedation | Richmond Agitation-Sedation Scale (RASS) is used for sedation assessment. Scores on RASS are recorded at tracheal extubation, every 5 minutes after extubation, and at 0, 30, 60, 120, 240 minutes after returning to the ward. If RASS>=2 during emergence from general anesthesia, the bolus injection of propofol 1.5-2.5mg/kg can be applied when necessary. |
At tracheal extubation, every 5 minutes after extubation, and at 0, 30, 60, 120, 240 minutes after returning to the ward | No |
Secondary | Sedative effectiveness | Verbal numerical rating scale (VNRS) is employed for assessment of pain intensity (PI). The scores range from 0-10: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain. In the operation room, the subject is asked to say the VNRS scores by the PACU nurse, and the score is recorded. The VNRS assessment is also conducted at 5, 15, 30 minutes after recovery from anesthesia, and at 0, 30, 60, 120, 240 minutes after returning to the ward. During emergence from general anesthesia, if VNRS score> = 6 points, a single-dose bolus injection of sufentanil 5 ug is applied; if pain is not alleviated, sufentanil 5 ug can be given again after 5 minutes, and total dose does not exceed 10 ug. |
Up to 240 minutes after returning to the ward | No |
Secondary | Test patient's blood pressure during maintenance of anesthesia | When MAP> 90 mmHg during maintenance of anesthesia, the amount of anesthetic drugs will be increased, i.e. the inhalation concentration of sevoflurane, propofol and/or remifentanil infusion dose. If the result is still not satisfactory, a single dose of nicardipine 0.5-1 mg via intravenous injection will be added. When MAP <60 mmHg, a single intravenous injection of ephedrine 5-10 mg can be given, while the value of MAP also can be adjusted by fluid replacement and reducing anesthetic doses (such as the inhalation concentration of sevoflurane, propofol, and/or remifentanil infusion dose) to adjust; if the effect is still not satisfactory, continuous infusion of 2% norepinephrine is recommended to maintain blood pressure in the target range. |
During maintenance of anesthesia | No |
Secondary | Monitor Patient's heart beat during maintenance of anesthesia | When HR> 90 beats/min or ST-T segment abnormalities on ECG appear during maintenance of anesthesia, a single dose of 5-10 mg esmolol can be given intravenously, and meanwhile, the fluid replacement is recommended. When HR <45 beats/min, a single dose of 0.3-0.5 mg atropine can be given intravenously; if the result is not satisfactory and repeated administration is up to the maximum cumulative amount of 2 mg, isoproterenol 1 mg/500 ml can be given intravenously and the infusion speed can be adjusted based on HR. | During maintenance of anesthesia | No |
Secondary | Test patient's blood pressure during anesthesia recovery period | If MAP> BV +20% lasts more than 1 minute during anesthesia recovery period, a single-dose bolus injection of nicardipine 0.5-1mg is given; if the result is not satisfactory, repeated doses (nicardipine 10 mg/100 ml) and the infusion rate can be adjusted according to blood pressure values. If MAP <70 mmHg lasts more than 1 minute, a single-dose bolus injection of ephedrine 5-10 mg bolus is preferred, and meanwhile, the fluid replacement is also introduced under the premise of exclusion of cardiogenic shock; if necessary, continuous infusion of 2% norepinephrine can be given to maintain the blood pressure in the target range. |
During anesthesia recovery period | No |
Secondary | Monitor Patient's heart beat during anesthesia recovery period | When HR> 120 beats/min or ST-T segment abnormalities on ECG appear during anesthesia recovery period, a load dose of esmolol 5-10 mg is necessary followed by continuous intravenous infusion of esmolol 100 mg/100 ml to control HR. The infusion rate is adjusted according to the value of HR. When HR <45 beats/min, the bolus injection of atropine 0.3-0.5 mg is given; if the result is not satisfactory and repeated administration is up to the maximum cumulative amount of 2 mg, repeated administration to the maximum cumulative amount 2mg, the intravenous infusion of isoproterenol 1 mg/500 ml can be given and the infusion rate is adjusted according to the HR value. |
during anesthesia recovery period | No |
Secondary | Observe chills reaction | If chills reaction appear when the patient emerges from general anesthesia, the intravenous injection of tramadol hydrochloride 0.1 g should be given slowly on the basis of heat preservation; if appearance of nausea and vomiting, the intravenous injection of tropisetron hydrochloride (Xinbei) 5 mg should be given. | At emerge from general anesthesia | No |
Secondary | To measure palinesthesia | Palinesthesia is evaluated by the surgeon based on a visual analogue scale VAS 0-10 points: 0=dissatisfied, 10=very satisfied. | At emerge from general anesthesia | No |
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