Effects of neuromuscular block reversal with sugammadex vs neostigmine on postoperative respiratory outcomes after major abdominal surgery. A randomized controlled trial.

Effects of neuromuscular block reversal with sugammadex vs neostigmine on postoperative respiratory outcomes after major abdominal surgery. A randomized controlled trial. - Sugammadex vs neostigmine on postoperative respiratory outcomes after major abdominal surgery.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005156-26-ES

Enrollment

Unknown

Registered

2015-01-26

Start date

2015-05-27

Completion date

Unknown

Last updated

2017-02-20

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

Conditions

Patients of both sexes proposed for major abdominal surgery under general anesthesia plus epidural

Interventions

Trade Name: Neostigmina Braun Product Name: Neostigmine Product Code: Reference Pharmaceutical Form: Solution for injection INN or Proposed INN: NEOSTIGMINE CAS Number: 588-17-0 Current Sponsor code:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who previously signed informed consent. Patients undergoing one of the following interventions: -Segmental hepatectomy, atypical or lobar. -Whipple pancreaticoduodenectomy cephalic and type reconstruction. -Pancreatic resection without reconstruction -Splenectomy. -Partial or total gastrectomy Partial or total colectomy with or without reconstruction transit 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: ? Do not give your consent. ? Come to the recovery unit mechanical ventilation. ? Have hypersensitivity reactions to any of the study drugs. ? A history of severe asthma or moderate asthma treated. ? Have a history of pulmonary fibrosis or very severe COPD (grade IV ranking GOLD). ? Have had myocardial infarction or coronary occlusion the three months prior to surgery. ? Have Myasthenia Gravis. ? Please specify emergency surgery. ? neuromuscular blockade was performed with non-steroidal blockers do not require pharmacological reversal of blockade. ? Do not have an epidural catheter for postoperative pain control.

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): Differences in the size of atelectasis measured by planimetry. Differences in the relationship pO2 / FiO2 in the first hour after surgery. Explore the accuracy of ultrasound to detect pulmonary atelectasis and its correlation with pO2 / FiO2, chest radiography and spirometry parameters;Timepoint(s) of evaluation of this end point: Differences in the size of atelectasis measured by planimetry. Differences in the relationship pO2 / FiO2 in the first hour after surgery. Explore the accuracy of ultrasound to detect pulmonary atelectasis and its correlation with pO2 / FiO2, chest radiography and spirometry parameters	—

Measure

Time frame

Secondary end point(s): Differences in the size of atelectasis measured by planimetry. Differences in the relationship pO2 / FiO2 in the first hour after surgery. Explore the accuracy of ultrasound to detect pulmonary atelectasis and its correlation with pO2 / FiO2, chest radiography and spirometry parameters;Timepoint(s) of evaluation of this end point: Differences in the size of atelectasis measured by planimetry. Differences in the relationship pO2 / FiO2 in the first hour after surgery. Explore the accuracy of ultrasound to detect pulmonary atelectasis and its correlation with pO2 / FiO2, chest radiography and spirometry parameters

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Primary

Measure	Time frame
Main Objective: Assess differences in the decline in forced vital capacity (FVC) among patients receiving sugammadex or neostigmine to reverse neuromuscular blockade.;Secondary Objective: Differences in the size of atelectasis measured by planimetry. Differences in pO2 / FiO2 ratio in the first hour after surgery. Explore the accuracy of ultrasound to detect pulmonary atelectasis and its correlation with pO2 / FiO2, chest radiography and spirometry parameters;Primary end point(s): The analysis of the primary endpoint were performed with the difference between CVFb (basal) and CFV1h (the first time) and the difference between CVFb and CVF24h. (forced vital capacity at 24h).;Timepoint(s) of evaluation of this end point: difference between CVFb (basal) and CFV1h (the first time) and the difference between CVFb and CVF24h. (forced vital capacity at 24h).	—

Measure

Time frame

Main Objective: Assess differences in the decline in forced vital capacity (FVC) among patients receiving sugammadex or neostigmine to reverse neuromuscular blockade.;Secondary Objective: Differences in the size of atelectasis measured by planimetry. Differences in pO2 / FiO2 ratio in the first hour after surgery. Explore the accuracy of ultrasound to detect pulmonary atelectasis and its correlation with pO2 / FiO2, chest radiography and spirometry parameters;Primary end point(s): The analysis of the primary endpoint were performed with the difference between CVFb (basal) and CFV1h (the first time) and the difference between CVFb and CVF24h. (forced vital capacity at 24h).;Timepoint(s) of evaluation of this end point: difference between CVFb (basal) and CFV1h (the first time) and the difference between CVFb and CVF24h. (forced vital capacity at 24h).

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Countries

Spain

Contacts

Public ContactManuel Román

Servicio de Farmacología Clínica

manuel.roman@salud.madrid.org+34915202540

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 2, 2026