Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02593942
Other study ID # YTU-2014
Secondary ID
Status Completed
Phase Phase 4
First received October 3, 2015
Last updated October 29, 2015
Start date January 2015
Est. completion date September 2015

Study information

Verified date October 2015
Source Yeditepe University Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial Summary

Total intravenous anaesthesia using propofol and remifentanil are routinely used drugs for this purpose. The hemodynamic stability and at the same time early emergency are the main goals following neurosurgery. However there is no standard for discontinuation time for manually controlled systems today.

The investigators aimed to study the effect of remifentanil infusion alone for early emergence and hemodynamic stability during the closure period in patients undergoing supratentorial craniotomy.


Description:

Adult, American society of Anaesthesiologist score I-II, 80 patients who underwent elective supratentorial craniotomy for tumour resection were randomly assigned to group I or II. In group I; propofol was discontinued during the dural closure. After the propofol was discontinued, remifentanil dose was increased with the guidance of bispectral index spectrum and hemodynamic parameters. In group II; propofol discontinued before the end of the surgery. Time to awakening and extubation time, adverse events, total remifentanil and propofol consumptions and side effects were recorded. Heart rate and blood pressure were recorded during this period.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- American Society of Anaesthesiologist physical status I-II

- Glasgow Coma Scale score of 15 points

- Elective supratentorial craniotomy for tumor resection

- Supine position

Exclusion Criteria:

- Obese patient

- Brain tumor greater than 30 mm in diameter

- Postoperative cranial drainage

- Hypertension

- Diabetes mellitus

- Reoperation

- Pregnant

- Breast feeding

- Allergy to the study medications

- History of cranial radiotherapy

- Frontal bone flap

- Intraoperative neuromonitoring

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Remifentanil
0.1-0.5 mcg/kg/min infusion
Propofol
75-200 mcg/kg/min infusion

Locations

Country Name City State
Turkey Yeditepe University Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Yeditepe University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time of extubation After the surgery, starting from three-pin head holder removal, an investigator asked each patient to open his or her eyes, squeeze the investigator's hand. When the patient opened his or her eyes, obeyed commands, resumed adequate respiration, hemodynamically stable and bispectral index spectrum > 70-80 was extubated, and the time will be recorded. The patients will be followed for an expected average of 3 hours. 3 hours No
Secondary Heart Rate Heart rate per minute was recorded 6 hours No
Secondary Mean arterial pressure were recorded Mean arterial pressure (mmHg) was recorded 6 hours No
Secondary Post-anesthesia awaking time Post-anesthesia awaking time assessed as the interval (min:sec)required to 3 hours No
See also
  Status Clinical Trial Phase
Completed NCT04607525 - Dexmedetomidine Infusion Effect on Hemodynamic Variables During Craniotomy Phase 4
Not yet recruiting NCT02929147 - Comparison of Efficacy and Safety of the Postoperative Analgesia Methods Phase 4
Completed NCT00389883 - Anaesthesia for Supratentorial Tumor Resection Phase 3
Completed NCT00972790 - Scalp Nerve Blocks for Post-Craniotomy Pain N/A
Completed NCT00179803 - Stem Cell Transplant for High Risk Central Nervous System (CNS) Tumors Phase 2
Recruiting NCT04316208 - Effect of PEEP on Subdural Pressure, Optic Nerve Sheath Diameter, Lung Compliance and Brain Perfusion Pressure N/A
Recruiting NCT02168075 - Mannitol Brain Relaxation Effect N/A
Completed NCT04941040 - Opioid Free VS Opioid Anesthesia for Craniotomies Phase 1
Recruiting NCT02113358 - Comparison of Stroke Volume Variation-guided Normovolemic and Restrictive Fluid Management During Craniotomy: a Randomized Controlled Trial N/A
Not yet recruiting NCT04344132 - Pre- vs. Postoperative Scalp Block for Pain Control After Supratentorial Craniotomy N/A