Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03817359
Other study ID # 2-107-05-079
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 3, 2018
Est. completion date December 27, 2018

Study information

Verified date January 2019
Source Tri-Service General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Co-administration of propofol and remifentanil is considered to be an ideal total intravenous anesthesia technique, which is widely used in induction and maintenance of general anesthesia. Remifentanil and propofol can be mixed in polypropylene syringes for one hour with a remaining concentration of 91% in small concentrations of remifentanil. However, delivery of remifentanil-propofol mixture by target-controlled infusion(TCI) for general anesthesia in surgical procedure has not been described. Breast cancer surgery ( including modified radical mastectomy and breast-conserving surgery) is a less time-consuming procedure for patients with breast cancer with one-hour duration in our hospital. This pilot study was to examine the merit of remifentanil-propofol mixture as a GA regimen for breast cancer surgery.


Description:

Previous studies has described the feasibility and safety of remifentanil-propofol mixture use in sedation of pediatric patients undergoing magnetic resonance imaging or flexible fiberoptic bronchoscopy.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date December 27, 2018
Est. primary completion date December 27, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- ASA II or III

- age more than 18 years

- scheduled for breast cancer surgery under general anesthesia.

Exclusion Criteria:

- previously allergic to propofol or remifentanil

- combining other surgical procedure leading to extended operative time

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
Remifentanil-propofol mixture
Participants receive total intravenous anesthesia with remifentanil-propofol mixture by single TCI pump in intervention group. All TCI target concentration adjustments or extra bolus of propofol or remifentanil during operation were based on BIS and ANI monitor.

Locations

Country Name City State
Taiwan Tri-Service General hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Bedocs P, Evers DL, Buckenmaier CC 3rd. Predosing Chemical Stability of Admixtures of Propofol, Ketamine, Fentanyl, and Remifentanil. Anesth Analg. 2018 Oct 3. doi: 10.1213/ANE.0000000000003772. [Epub ahead of print] — View Citation

Berkenbosch JW, Graff GR, Stark JM, Ner Z, Tobias JD. Use of a remifentanil-propofol mixture for pediatric flexible fiberoptic bronchoscopy sedation. Paediatr Anaesth. 2004 Nov;14(11):941-6. — View Citation

Stewart JT, Warren FW, Maddox FC, Viswanathan K, Fox JL. The stability of remifentanil hydrochloride and propofol mixtures in polypropylene syringes and polyvinylchloride bags at 22 degrees-24 degrees C. Anesth Analg. 2000 Jun;90(6):1450-1. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of TCI device adjustments Total times of TCI pump adjustment during procedure
Secondary Mean blood pressure measured by non-invasive blood pressure cuff at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes
Secondary Heart rate recorded by ECG and pulse oximetry at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes
Secondary Patient satisfaction Rating of satisfaction by questionnaire the 1 day after operation
Secondary postoperative analgesia rescue Analgesics use during PACU stay An average of 30 minutes after arriving at PACU
Secondary Total dose of remifentanil total consumption of remifentanil during procedure At the end of surgery
Secondary Total dose of propofol total consumption of propofol during procedure At the end of surgery
See also
  Status Clinical Trial Phase
Completed NCT04235894 - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Completed NCT05103735 - Propofol-remifentanyl Versus Dexmedetomidine in Awake Craniotomy: Impact on Electroclinical Seizure Activity
Recruiting NCT06210061 - Propofol-Fentanyl-Dexmedetomidine and Propofol-Fentanyl-Sevoflurane Anesthesia for Major Spine Surgery Under Somato Sensory- and Motor- Evoked Potential Monitoring N/A
Completed NCT06098196 - Effects of Aminophylline Bolus on TCI (Target Controlled Infusion) Concentrations at Return of Responsiveness
Completed NCT06098209 - Dexmedetomidine and Propofol in Mechanically Ventilated Patients by Using Salivary Alpha-amylase as a Stress Marker N/A
Completed NCT04805775 - Desflurane and Postoperative Sleep Quality in Patients Undergoing Elective Breast Surgery N/A
Recruiting NCT05533580 - Differential Effects of Remimazolam and Propofol on Dynamic Cerebral Autoregulation During General Anesthesia N/A
Recruiting NCT05971121 - Comparing Ciprofol and Propofol for Sedation in Hypotensive ICU Patients: a Single Center Prospective Cohort Study
Recruiting NCT05533567 - Electroencephalographic Profiles During General Anesthesia: a Comparative Study of Remimazolam and Propofol N/A
Completed NCT06243822 - Ketamine Versus Propofol as ICU Sedation Phase 4
Completed NCT03741361 - The Impact of Anxiety or Depression on the Sedative Concentration of Propofol
Recruiting NCT06403852 - Investigating Near-Threshold Perception During Anesthetic Sedation Phase 2
Not yet recruiting NCT06386965 - Sevoflurane Versus Propofol: Effect on Stress Response
Recruiting NCT02687568 - Values of Enhanced Monitoring by EEG Recording (Narcotrend) for Sedation in Colonoscopy N/A
Completed NCT01941888 - Propofol TCI Administered by Gastroenterologists During Endoscopy: a Randomized Double Blind Controlled Study Phase 4
Completed NCT04123249 - The Effects of Intravenous Anesthetics and Inhaled Anesthetics on Patients' Postoperative Sleep N/A
Recruiting NCT05352685 - Effects of Propofol on Auditory Event-related Potentials and Brain Functional Connectivity in Patients With Supratentorial Glioma N/A
Completed NCT05800288 - Effect of Midazolam Bolus on Eleveld and Schnider TCI (Target Controlled Infusion) Models
Recruiting NCT04729478 - Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea N/A
Completed NCT04394897 - Total Intravenous Anesthesia With Remifentanil-propofol Admixture