NCT00298831

Use of Sugammadex at the End of Case in Routine Anesthesia (MK-8616-023)

Completed Phase 3 Results posted Last updated 27 March 2019

What this trial tests

Phase 3 trial testing Sugammadex in Anesthesia, General in 224 participants. Completed in 22 May 2006.

Timeline

27 October 2005

Primary endpoint
22 May 2006

22 May 2006

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	224
Start date	27 October 2005
Primary completion	22 May 2006
Estimated completion	22 May 2006

Drugs / interventions tested

• Sugammadex — full drug profile →
• Rocuronium (ROCURONIUM) — full drug profile →

Conditions studied

• Anesthesia, General — all drugs for Anesthesia, General →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

18 and older, any sex, with Anesthesia, General. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.9 Primary · Up to approximately 30 minutes following administration of study treatment

Mean time from start of MK-8616 administration to recovery of participant T4/T1 ratio to 0.9 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the partici

Group	Value	95% CI
Sugammadex	2.32	± 2.15

Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.7 Secondary · Up to approximately 10 minutes following administration of study treatment

Mean time from start of MK-8616 administration to recovery of participant T4/T1 ratio to 0.7 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the partici

Group	Value	95% CI
Sugammadex	1.50	± 1.07

Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.8 Secondary · Up to approximately 15 minutes following administration of study treatment

Mean time from start of MK-8616 administration to recovery of participant T4/T1 ratio to 0.8 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the partici

Group	Value	95% CI
Sugammadex	1.80	± 1.37

Clinical Assessment of Recovery - Participant's Level of Consciousness Secondary · Up to 24 hours

The quality of recovery was assessed by asking the participant 40 questions from a validated Quality of Recovery Questionnaire (QoR-40). Participants were assessed for level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation), if applicable, by asking their name, if they are aware of where they are, and what day it is. Assessment 1 occurred prior to transfer to the recovery room after extubation and Assessment 2 occurred prior to discharge from the recovery room.

Awake and oriented - Assessment 1

Group	Value	95% CI
Sugammadex	138

Awake and oriented - Assessment 2

Group	Value	95% CI
Sugammadex	184

Arousable with minimal stimulation - Assessment 1

Group	Value	95% CI
Sugammadex	51

Arousable with minimal stimulation - Assessment 2

Group	Value	95% CI
Sugammadex	12

Responsive only to tactile stimulation - Assess. 1

Group	Value	95% CI
Sugammadex	8

Responsive only to tactile stimulation - Assess. 2

Group	Value	95% CI
Sugammadex	0

Clinical Assessments of Recovery - Participant Able to Perform 5-second Head Lift (5SHL) Secondary · Up to 24 hours

5-second head lift test was assessment of the ability of the participant to lift the head for 5 seconds and was performed by a blinded safety assessor. Tests were repeated every 15 minutes until the participant could successfully perform the 5-second head-lift. Assessment 1 occurred prior to transfer to the recovery room after extubation and Assessment 2 occurred prior to discharge from the recovery room.

Able to perform 5SHL during Assessment 1

Group	Value	95% CI
Sugammadex	173

Able to perform 5SHL during Assessment 2

Group	Value	95% CI
Sugammadex	196

Clinical Assessments of Recovery - Check for General Muscle Weakness (GMW) Secondary · Up to 24 hours

General muscle weakness check was assessed by the investigator. The assessment of general muscle weakness was based on a scale from 0-10, with 0 representing total paralysis, 1 signifying extreme impairment, 9 for close to no impairment, and 10 for normal muscle strength. Scores of 3, 4, 5, etc. denoted increasing muscle strength in approximately 10% increments. Scores of 9 and lower were denoted as GMW. Assessment 1 occurred prior to transfer to the recovery room after extubation and assessment 2 occurred prior to discharge from the recovery room.

GMW present during Assessment 1

Group	Value	95% CI
Sugammadex	4

GMW present during Assessment 2

Group	Value	95% CI
Sugammadex	9

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 7 days after study drug administration. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Sugammadex

Serious: 8/197 (4%)

Deaths: 0/197

Serious adverse events (14 terms)

Reaction	System	Sugammadex
Electromechanical dissociation	Cardiac disorders	—
Ileus	Gastrointestinal disorders	—
Large intestine perforation	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Pain	General disorders	—
Sepsis	Infections and infestations	—
Peroneal nerve injury	Injury, poisoning and procedural complications	—
Procedural complication	Injury, poisoning and procedural complications	—
Radiculitis brachial	Nervous system disorders	—
Delirium	Psychiatric disorders	—
Psychiatric symptom	Psychiatric disorders	—
Suicidal ideation	Psychiatric disorders	—
Renal failure acute	Renal and urinary disorders	—
Apnoea	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (19 terms — click to expand)

Reaction	System	Sugammadex
Procedural pain	Injury, poisoning and procedural complications	—
Nausea	Gastrointestinal disorders	—
Dizziness	Nervous system disorders	—
Vomiting	Gastrointestinal disorders	—
Pyrexia	General disorders	—
Headache	Nervous system disorders	—
Incision site complication	Injury, poisoning and procedural complications	—
Back pain	Musculoskeletal and connective tissue disorders	—
Insomnia	Psychiatric disorders	—
Constipation	Gastrointestinal disorders	—
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	—
Pruritus	Skin and subcutaneous tissue disorders	—
Chills	General disorders	—
Procedural hypertension	Injury, poisoning and procedural complications	—
Bladder spasm	Renal and urinary disorders	—
Procedural hypotension	Injury, poisoning and procedural complications	—
Anaemia	Blood and lymphatic system disorders	—
Neutrophil count increased	Investigations	—
Anxiety	Psychiatric disorders	—

Most-reported serious reactions: Electromechanical dissociation, Ileus, Large intestine perforation, Nausea, Pain, Sepsis, Peroneal nerve injury, Procedural complication.

Data from ClinicalTrials.gov NCT00298831 adverse events section.

Sponsor's own description

The primary purpose of the study is to determine the time-course of recovery to a T4/T1 ratio of 0.9 within 4 minutes after 4.0 mg.kg\^-1 Sugammadex is administered at least 15 minutes after the last administration of rocuronium in a wide range of surgical procedures and anesthetic regimens (routine use). Safety evaluation is part of the study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Sugammadex is effective in reversing rocuronium in the presence of antibiotics.
   Hudson ME, Rietbergen H, Chelly JE. · · 2014 · cited 1× · PMID 25157214 · DOI 10.1186/1471-2253-14-69