Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06018623
Other study ID # TOTM
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 15, 2024
Est. completion date November 30, 2024

Study information

Verified date March 2024
Source Inonu University
Contact duygu demiroz, dr
Phone 905319504421
Email drduygudemiroz@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients who will be anesthesia induced with propofol will be body analyzed with Tanita before the operation. Height, weight, age, gender and other general information of the patients will be recorded. Total body weight (TBW), ideal body weight (IBW) and lean body weight (LBW) will be calculated. Patients over 18 years of age who will be operated under general anesthesia for 2-6 hours will be included. Patients allergic to propofol or contraindicated to propofol will be excluded. In the study, in order to decide and test the most appropriate weight-based scale for the evaluation of propofol dosage for induction of anesthesia by identifying patients who need additional propofol during intubation, Ingrande et al. After monitoring, propofol infusion (100 mg/kg/hour) will be started according to total body weight and the infusion will be stopped when the BIS value is between 50 and 40 and the elapsed time will be recorded. Routine anesthesia applications will be performed by applying neuromuscular blocker. Total Propofol dose administered will be calculated according to the dose TBW, IBW and LBW in kilograms. The relationship between the doses administered and body mass index will be evaluated.


Description:

Patients who will be anesthesia induced with propofol will be body analyzed with Tanita before the operation. Height, weight, age, gender and other general information of the patients will be recorded. Total body weight (TBW), ideal body weight (IBW) and lean body weight (LBW) will be calculated. Patients over 18 years of age who will be operated under general anesthesia for 2-6 hours will be included. Patients who are allergic to propofol or for whom propofol is contraindicated will not be included in the study. In the study, 80 patients with a mean body mass index [BMI] between 18-35 and Bispectoral index (BIS) (Ingrande et al. ) monitoring, propofol infusion (100 mg/kg/hour) will be started according to total body weight, and when the BIS value is between 50 and 40, the infusion will be stopped and the elapsed time will be recorded in order to decide and test the most appropriate weight-based scale for propofol dosing for anesthesia induction to identify and evaluate patients who need additional propofol during intubation. Routine anesthesia will be performed by applying neuromuscular blocker. Total Propofol dose administered will be calculated according to TBW, IBW and LBW per kilogram. And the relationship between the doses given and body mass index will be evaluated. In our study, we aimed to evaluate the effects of Propofol dose according to lean body weight by evaluating patients with a body mass index below 35.Patients who will undergo anesthesia induction with Propofol will undergo preoperative body analysis with Tanita. Height, weight, age, gender and other general information of the patients will be recorded. Total body weight (TBW), ideal body weight (IBW) and lean body weight (LBW) will be calculated. Patients over 18 years of age who will be operated under general anesthesia for 2-6 hours will be included. Patients who are allergic to propofol or for whom propofol is contraindicated will not be included in the study. In the study, 80 patients with a mean body mass index [BMI] between 18-35 and Bispectoral index (BIS) (Ingrande et al. ) monitoring, propofol infusion (100 mg/kg/hour) will be started according to total body weight, and when the BIS value is between 50 and 40, the infusion will be stopped and the elapsed time will be recorded in order to decide and test the most appropriate weight-based scale for propofol dosing for anesthesia induction to identify and evaluate patients who need additional propofol during intubation. Routine anesthesia will be performed by applying neuromuscular blocker. Total Propofol dose administered will be calculated according to TBW, IBW and LBW per kilogram. And the relationship between the doses given and body mass index will be evaluated. In our study, we aimed to evaluate the effects of Propofol dose according to lean body weight by evaluating patients with a body mass index below 35.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date November 30, 2024
Est. primary completion date October 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: BMI 18-35 will be included. over 18 years old It will take 2-6 hours Patients who will be operated under general anesthesia will be included. - Exclusion Criteria: PATIENT DOESN'T WANT CONTRAINDICATION OF PROPOFOL Propofol allergy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
It is an observational study and no non-routine procedures will be performed on patients. Routine anesthesia procedure will be applied to the patients
It is an observational study and no non-routine procedures will be performed on patients. Routine anesthesia procedure will be applied to the patients

Locations

Country Name City State
Turkey Inonu universitesi Malatya

Sponsors (1)

Lead Sponsor Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Barras M, Legg A. Drug dosing in obese adults. Aust Prescr. 2017 Oct;40(5):189-193. doi: 10.18773/austprescr.2017.053. Epub 2017 Oct 3. No abstract available. — View Citation

Fujimoto M, Tanahira C, Nishi M, Yamamoto T. In non-obese patients, duration of action of rocuronium is directly correlated with body mass index. Can J Anaesth. 2013 Jun;60(6):552-6. doi: 10.1007/s12630-013-9914-x. Epub 2013 Mar 6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary PROPOFOL DOSE THE RATIO OF PROPOFOL DOSE WITH SUFFICIENT DEPTH OF ANESTHESIA ACCORDING TO TOTAL AND LEATHER BODY WEIGHT 2
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04279054 - Decreased Neuraxial Morphine After Cesarean Delivery Early Phase 1
Active, not recruiting NCT04580030 - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Recruiting NCT04099693 - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated NCT02481999 - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed NCT04235894 - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Recruiting NCT05525104 - The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen). N/A
Recruiting NCT05024084 - Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth Phase 4
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03277872 - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope N/A
Terminated NCT03940651 - Cardiac and Renal Biomarkers in Arthroplasty Surgery Phase 4
Terminated NCT02529696 - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Terminated NCT03704285 - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting NCT05259787 - EP Intravenous Anesthesia in Hysteroscopy Phase 4
Completed NCT02894996 - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient? N/A
Completed NCT05386082 - Anesthesia Core Quality Metrics Consensus Delphi Study
Terminated NCT03567928 - Laryngeal Mask in Upper Gastrointestinal Procedures N/A
Recruiting NCT06074471 - Motor Sparing Supraclavicular Block N/A
Completed NCT04163848 - CARbon Impact of aNesthesic Gas