Trial Outcomes & Findings for Comparison of Surgical Conditions in Cesarean Section Under General Anesthesia With Deep Neuromuscular Blockade Versus Succinylcholine (NCT NCT01941628)

Results Overview

Induction to delivery interval will be used as primary keypoint for surgical conditions comparison.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

91 participants

Primary outcome timeframe

24 hrs

Results posted on

2019-02-11

Participant Flow

The study was conducted at a tertiary care university hospital in the period between August 2014 and September 2016.

Participant milestones

Participant milestones
Measure	Rocuronium Rocuronium 0.6 mg/kg was used as muscle relaxant to allow intubation during induction into general anesthesia and to induce deep neuromuscular blockade for the surgery. Deep neuromuscular blockade was maintained thorough the surgery until the suture of fascia of musculus rectus abdominis.	Succinylcholine Standard induction into general anesthesia with succinylcholine 1 mg/kg was performed. Atracurium 0.25 mg/kg was administered during the surgery on surgeon's request.
Overall Study STARTED	46	45
Overall Study COMPLETED	45	45
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rocuronium n=45 Participants Rocuronium 0.6 mg/kg was used as muscle relaxant to allow intubation during induction into general anesthesia and to induce deep neuromuscular blockade for the surgery. Deep neuromuscular blockade was maintained thorough the surgery until the suture of fascia of musculus rectus abdominis.	Succinylcholine n=45 Participants Standard induction into general anesthesia with succinylcholine 1 mg/kg was performed. Atracurium 0.25 mg/kg was administered during the surgery on surgeon's request.	Total n=90 Participants Total of all reporting groups
Age, Continuous	33 years n=45 Participants	34 years n=45 Participants	33 years n=90 Participants
Sex: Female, Male Female	45 Participants n=45 Participants	45 Participants n=45 Participants	90 Participants n=90 Participants
Sex: Female, Male Male	0 Participants n=45 Participants	0 Participants n=45 Participants	0 Participants n=90 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 24 hrs

Induction to delivery interval will be used as primary keypoint for surgical conditions comparison.

Outcome measures

Outcome measures
Measure	Rocuronium n=45 Participants Rocuronium 0.6 mg/kg was used as muscle relaxant to allow intubation during induction into general anesthesia and to induce deep neuromuscular blockade for the surgery. Deep neuromuscular blockade was maintained thorough the surgery until the suture of fascia of musculus rectus abdominis.	Succinylcholine n=45 Participants Standard induction into general anesthesia with succinylcholine 1 mg/kg was performed. Atracurium 0.25 mg/kg was administered during the surgery on surgeon's request.
Induction to Delivery Interval	268 seconds Standard Deviation 73	276 seconds Standard Deviation 63

PRIMARY outcome

Timeframe: 24 hours

Population: The number of participants with a newborn in need of respiratory support

The number of participants with a newborn in need of respiratory support will be the primary safety measure in comparison of the influence of different neuromuscular blockade levels on newborn adaptation.

Outcome measures

Outcome measures
Measure	Rocuronium n=45 Participants Rocuronium 0.6 mg/kg was used as muscle relaxant to allow intubation during induction into general anesthesia and to induce deep neuromuscular blockade for the surgery. Deep neuromuscular blockade was maintained thorough the surgery until the suture of fascia of musculus rectus abdominis.	Succinylcholine n=45 Participants Standard induction into general anesthesia with succinylcholine 1 mg/kg was performed. Atracurium 0.25 mg/kg was administered during the surgery on surgeon's request.
Number of Participants With Newborn in Need of Respiratory Support	0 participants	0 participants

SECONDARY outcome

Timeframe: 5 days

A total number of surgical complications evaluated at day 5 after Caesarean delivery.

Outcome measures

Outcome measures
Measure	Rocuronium n=45 Participants Rocuronium 0.6 mg/kg was used as muscle relaxant to allow intubation during induction into general anesthesia and to induce deep neuromuscular blockade for the surgery. Deep neuromuscular blockade was maintained thorough the surgery until the suture of fascia of musculus rectus abdominis.	Succinylcholine n=45 Participants Standard induction into general anesthesia with succinylcholine 1 mg/kg was performed. Atracurium 0.25 mg/kg was administered during the surgery on surgeon's request.
Peroperative and Postoperative Surgical Complication	0 participants	0 participants

Adverse Events

Rocuronium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Succinylcholine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Assoc. Prof. Jan Blaha, MD, PhD

Dept. of Anaesthesiology and Intensive Medicine, General University Hospital in Prague

Phone: +420 224962243

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place