Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03193320
Other study ID # 1701
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date December 1, 2023

Study information

Verified date March 2020
Source Policlinica Metropolitana
Contact Renzo G Di Natale, MD
Phone +584122715908
Email renzogdg@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single-center prospective randomized control trial (RCT) to determine whether the continuous monitoring of the plethysmographic variability index (PVI) during low-risk surgeries, can be used to optimize the intraoperative fluid administration. Low-risk patients that attend our day surgery unit, and who will be operated under general anesthesia, will be randomized to either a liberal fluid group, a restrictive fluid group or a dynamic monitoring group (PVI-directed). The amount of fluid infused together with the time to discharge, will be assessed in each participant during the postoperative period along with additional secondary outcomes.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 243
Est. completion date December 1, 2023
Est. primary completion date December 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- participants attending the unit for a day surgery procedure

- participants whose surgeries will be performed under general anesthesia

- aged between 18-65 years

- no abnormal findings on chest x-ray or electrocardiogram on preoperative evaluation

- patients undergoing procedures which do not require opening of the abdominal or thoracic cavities

Exclusion Criteria:

- ASA score III or higher

- patients undergoing surgeries which require additional pain management procedures (e.g. selective nerve blockade, epidural anesthesia, etc.)

- known pregnant women

- known kidney disease (or serum creatinine >1.8 mg/dl)

- known liver disease (or AST/ALT >60 U/l)

- known chronic heart failure (determined by a LVEF <55%)

- participants who develop hypotension intraoperatively and do not respond to 4 fluid challenges (1000 ml), requiring aggressive fluid resuscitation OR vasopressors

- estimated blood loss during surgery >250 ml

- development of an adverse reaction to any of the drugs administered during surgery (requiring additional medical management)

Study Design


Intervention

Other:
Fluid therapy protocol
Only ringer lactate (RL solution will be used). 1. Fluid loading at induction with 500 ml of ringer lactate solution will be given to some groups. 2. Base infusion rate varies according to group. 3. Fluid challenges - infusion of 250 ml over 5 min, a hemodynamic parameter specific to each group will be monitored for 10 min after the end of infusion to look for changes. Patients who do not respond to four (4) fluid challenges (volume infused 1000 ml) will be excluded.

Locations

Country Name City State
Venezuela Policlinica Metropolitana Caracas Miranda

Sponsors (1)

Lead Sponsor Collaborator
Policlinica Metropolitana

Country where clinical trial is conducted

Venezuela, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total volume of fluid infused intraoperatively Total volume of ringer lactate solution infused intraoperatively to participants (ml). 0 min after extubation
Primary Time to discharge Time in hours (h) from anesthesia reversal to fulfillment of patient discharge criteria. Patients will be assessed by an attending nurse every 30 min to assess the fulfillment of these criteria. 240 min after extubation (discharge)
Secondary Significant postoperative nausea and vomiting (PONV) Presence of significant PONV as determined by a score =5 on the scale proposed by Myles SA et al. (BJA 2012) 240 min after extubation (discharge)
Secondary Postoperative dizziness Presence of patient self-reported dizziness in the post-operative period. 30 min after reversal
Secondary Postoperative fatigue Presence of patient self-reported fatigue after surgery. 30 min after reversal
Secondary Postoperative thirst Presence of patient self-reported thirst after surgery 30 min after reversal
See also
  Status Clinical Trial Phase
Recruiting NCT06063798 - Respiratory Effects of Flow-Controlled Ventilation and Jet Ventilation in Patients Undergoing Laryngotracheal Surgery N/A
Not yet recruiting NCT05035069 - Efficacy and Safety of Ciprofol Compared to Propofol for Nonintubated General Anesthesia in Patients Undergoing TAVR Phase 4
Completed NCT03861364 - Hemodynamics During Induction of General Anesthesia With High and Low Propofol Dose. Phase 4
Completed NCT02711280 - The Effect of Anesthetics on Oxidative Stress and Apoptosis Status in Children N/A
Completed NCT01199471 - Estimate the Behavior of Chinese Anesthesiologists Practicing General Anesthesia With Sevoflurane N/A
Completed NCT00917033 - Tracheal Intubation of Morbidly Obese Patients. GlideScope Versus Direct Laryngoscopy Phase 4
Completed NCT00391885 - Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by Entropy Phase 4
Completed NCT00552617 - A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part B: Caucasian Participants (P05971) Phase 2
Completed NCT03705026 - Relationship Between Genetic Polymorphism and Postoperative Nausea and Vomiting in Chinese Han Population
Completed NCT00552929 - A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Caucasian Participants. Part B (P05974) Phase 2
Completed NCT00475215 - Safety and Efficacy of Sugammadex (Org 25969, MK-8616) in Participants With or Having a Past History of Pulmonary Disease (19.4.308) (P05932) (MK-8616-017) Phase 3
Completed NCT00298831 - Use of Sugammadex at the End of Case in Routine Anesthesia (MK-8616-023) Phase 3
Recruiting NCT03943745 - EEG Changes During Induction of Propofol Anesthesia
Completed NCT03697642 - Nasopharyngeal Airway Guide Nasogastric Tube Placement N/A
Completed NCT04595591 - Observation of Propofol Titration at Different Speeds N/A
Not yet recruiting NCT05841316 - The ED95 Dose of Sugammadex to Reverse Rocuronium-Induced Deep Neuromuscular Block Back to Shallow Neuromuscular Block
Completed NCT04532502 - Impact of Anesthetic Environment the Sex Ratio of the Children of Female Assistants
Completed NCT03330236 - EEG - Guided Anesthetic Care and Postoperative Delirium N/A
Recruiting NCT06205212 - High-flow Nasal Oxygenation During Preoxygenation and Atelectasis N/A
Completed NCT00379613 - Use of Sugammadex Administered at 5 Minutes After Administration of 1.2 mg/kg Esmeron® (19.4.205)(P05942) Phase 2