IMPLICATION OF TWO ANESTHETIC TECHNIQUES TO REDUCE BLOOD LOSS IN CORRECTIVE JAW SURGERY.

IMPLICATION OF TWO ANESTHETIC TECHNIQUES: SEVOFLURANE VERSUS PROPOFOL TO REDUCE BLOOD LOSS IN ORTHOGNATHIC SURGERY

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002197-13-ES

Enrollment

Unknown

Registered

2016-10-26

Start date

2017-02-20

Completion date

Unknown

Last updated

2017-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Assessment of the bleeding in ortognatic surgery.

Interventions

Trade Name: SEVORANE Product Name: SEVORANE Product Code: 61.451 Pharmaceutical Form: Inhalation vapour, liquid INN or Proposed INN: Sevoflurane CAS Number: 28523-86-6 Other descriptive name: SEVOFLUR

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients = 18 and = 65 years old. • Classification ASA (American Society of Anesthesiologists) I or II. • orthognathic surgery scheduled bimaxillary • Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Patients who do not wish to consent to participate in the study. • Hemodynamic instability determined by the need for continuous infusion of inotropic or vasopressor. • Severe heart disease (Grades III and IV, NYHA) • Kidney disease (creatinine clearance = 30 mL / min) • Liver disease (Grade C Child-Pugh). • Diabetes Mellitus Type I or II compensated or decompensated. • Previous surgery in the surgical field including orthognathic surgery. • Patients with treatments or diseases affecting the coagulation cascade or platelet aggregation.

Design outcomes

Primary

Measure	Time frame
Main Objective: Quantification of blood loss in orthognathic surgery comparing Propofol against Sevoflurane.;Primary end point(s): Total intra-operative bleeding or surgical difficulty (subjective);Timepoint(s) of evaluation of this end point: At the end of surgery.;Secondary Objective: To compare the incidence of adverse events, especially the appearance of postoperative nausea and vomiting between the two drugs. Evaluation of postoperative facial edema. Assess the immediate and late postoperative pain. Evaluation of bleeding in surgical field according to the scale of Fromme. Assessing the degree of patient satisfaction.	—

Measure

Time frame

Main Objective: Quantification of blood loss in orthognathic surgery comparing Propofol against Sevoflurane.;Primary end point(s): Total intra-operative bleeding or surgical difficulty (subjective);Timepoint(s) of evaluation of this end point: At the end of surgery.;Secondary Objective: To compare the incidence of adverse events, especially the appearance of postoperative nausea and vomiting between the two drugs. Evaluation of postoperative facial edema. Assess the immediate and late postoperative pain. Evaluation of bleeding in surgical field according to the scale of Fromme. Assessing the degree of patient satisfaction.

—

Secondary

Measure	Time frame
Secondary end point(s): Demographic variables: •Age • Sex •Weight •Height • Body Mass Index Time variables: • Duration of surgery • Duration of anesthesia Anesthetic variables: • Mean arterial pressure (MAP) • Systolic blood pressure (SBP) • diastolic blood pressure (DBP) • Total dose administered per kg weight of intraoperative remifentanil and opioids.;Timepoint(s) of evaluation of this end point: At the start of the study: Demographic variables. At the end of surgery: Time and anesthetic variables.	—

Measure

Time frame

Secondary end point(s): Demographic variables: •Age • Sex •Weight •Height • Body Mass Index Time variables: • Duration of surgery • Duration of anesthesia Anesthetic variables: • Mean arterial pressure (MAP) • Systolic blood pressure (SBP) • diastolic blood pressure (DBP) • Total dose administered per kg weight of intraoperative remifentanil and opioids.;Timepoint(s) of evaluation of this end point: At the start of the study: Demographic variables. At the end of surgery: Time and anesthetic variables.

—

Countries

Spain

Contacts

Public ContactBLANCA

Servicio de Anestesiología y Reanimación

34912077558

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026