Small-dose Dexmedetomidine Effects on Recovery Profiles of Supratentorial Tumors Patients From General Anesthesia

NCT02007798 | Unknown DMC

• 1 other identifier: CMU-1st-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Neoplasms; Surgery

Keywords

dexmedetomidine; supratentorial tumors

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Time of recovery from anesthesia

  From the anesthetic induction to extubation

• Cough assessment at tracheal extubation

  At tracheal extubation

• Degree of sedation

  At tracheal extubation, every 5 minutes after extubation, and at 0, 30, 60, 120, 240 minutes after returning to the ward

• Sedative effectiveness

  Up to 240 minutes after returning to the ward

• Test patient's blood pressure during maintenance of anesthesia

  During maintenance of anesthesia

Study Arms (3)

low-dose group

EXPERIMENTAL

S group : dexmedetomidine is infused intravenously at a dose of 0.4 ug/kg

Drug: dexmedetomidine

middle-dose group

EXPERIMENTAL

M group: dexmedetomidine is infused intravenously at a dose of 0.8 ug/kg

Drug: dexmedetomidine

control group

EXPERIMENTAL

P group: normal saline is infused intravenously

Drug: normal saline

Interventions

dexmedetomidine DRUG

2 ml of dexmedetomidine at a concentration of 100 ug/ml is diluted by 98 ml normal saline to a concentration of 2 ug/ml. The required amount of experimental drugs is confirmed according to the weight and grouping, and diluted using normal saline to 20 ml.

Also known as: SFDA Approval No. H20090248, produced by Jiangsu Hengrui Medicine Co., Ltd., China.

low-dose group; middle-dose group

normal saline DRUG

100 ml per bag

Also known as: provided by the Central Pharmacy of the hospital

control group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 β-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, Ⅱ grade and grade Ⅱ 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.

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

Yue Yun

Shenyang, Liaoning, 110001, China

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Supratentorial Neoplasms

Interventions

Dexmedetomidine; Long-Term Synaptic Depression; Saline Solution

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ling Pei

  Department of Anesthesiology, the First Affiliated Hospital of China Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue Yun, Master

CONTACT

008613889168717; crazy_mouse0707@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Randomized, parallelled and double-blinded trial of small-dose dexmedetomidine effects on recovery profiles of supratentorial tumors patients from general anesthesia

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: December 11, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

CN (1)