NCT00474617

Comparison of the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616; Org 25969) in Elderly Participants With Adult Participants (MK-8616-029)

Completed Phase 3 Results posted Last updated 2 April 2019

What this trial tests

Phase 3 trial testing Sugammadex in Anesthesia, General in 162 participants. Completed in 20 October 2006.

Timeline

29 December 2005

Primary endpoint
20 October 2006

20 October 2006

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	162
Start date	29 December 2005
Primary completion	20 October 2006
Estimated completion	20 October 2006

Drugs / interventions tested

• Sugammadex — full drug profile →
• Rocurium — 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.

Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9 Primary · up to 10 minutes from start of sugammadex

Neuromuscular function was monitored by applying repetitive train-of-four (TOF) electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds \& assessing twitch response at the adductor pollicis muscle. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.9. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery.

Group	Value	95% CI
Participants 18 to 64 Years Old	2.53	± 1.35
Participants 65 to 74 Years Old	2.92	± 1.63
Participants 75 Years and Older	3.93	± 1.67

Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7 Secondary · up to 10 minutes from start of sugammadex

Neuromuscular function was monitored by applying repetitive train-of-four (TOF) electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds \& assessing twitch response at the adductor pollicis muscle. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.7. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery.

Group	Value	95% CI
Participants 18 to 64 Years Old	1.77	± 0.78
Participants 65 to 74 Years Old	2.10	± 1.47
Participants 75 Years and Older	2.68	± 1.17

Mean Time From Start of Administration of to Recovery of the T4/T1 Ratio to 0.8 Secondary · up to 10 minutes from start of sugammadex

Neuromuscular function was monitored by applying repetitive train-of-four (TOF) electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds \& assessing twitch response at the adductor pollicis muscle. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.8. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery.

Group	Value	95% CI
Participants 18 to 64 Years Old	2.05	± 0.98
Participants 65 to 74 Years Old	2.38	± 1.55
Participants 75 Years and Older	3.10	± 1.35

Participants Level of Consciousness Prior to Transfer to the Recovery Room After Extubation Secondary · Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)

Participants level of consciousness was assessed post-extubation and prior to transfer to recovery room. The levels were reported as: awake and oriented; arousable with minimal stimulation; responsive only to tactile stimulation. The number of participants in each of the 3 categories was summarized.

Awake and oriented

Group	Value	95% CI
Participants 18 to 64 Years Old	24
Participants 65 to 74 Years Old	38
Participants 75 Years and Older	21

Arousable with minimal stimulation

Group	Value	95% CI
Participants 18 to 64 Years Old	21
Participants 65 to 74 Years Old	22
Participants 75 Years and Older	17

Responsive only to tactile stimulation

Group	Value	95% CI
Participants 18 to 64 Years Old	2
Participants 65 to 74 Years Old	1
Participants 75 Years and Older	2

Participants Level of Consciousness Prior to Discharge From Recovery Room Secondary · Prior to Discharge from Recovery Room (up to 24 hours)

Participants level of consciousness was assessed prior to discharge from the recovery room. The levels were reported as: awake and oriented; arousable with minimal stimulation; responsive only to tactile stimulation. The number of participants in each of the 3 categories was summarized.

Awake and oriented

Group	Value	95% CI
Participants 18 to 64 Years Old	43
Participants 65 to 74 Years Old	56
Participants 75 Years and Older	36

Arousable with minimal stimulation

Group	Value	95% CI
Participants 18 to 64 Years Old	3
Participants 65 to 74 Years Old	2
Participants 75 Years and Older	2

Responsive only to tactile stimulation

Group	Value	95% CI
Participants 18 to 64 Years Old	0
Participants 65 to 74 Years Old	0
Participants 75 Years and Older	0

Number of Participants With General Muscle Weakness Prior to Transfer to the Recovery Room After Extubation Secondary · Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)

The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from neuromuscular blockade post-extubation and prior to transfer to recovery room. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups and the overall assessments were reported as "yes" or "no" to general muscle weakness. Participants who were not cooperative with the examination were not included in the assessment.

Group	Value	95% CI
Participants 18 to 64 Years Old	0
Participants 65 to 74 Years Old	3
Participants 75 Years and Older	1

Number of Participants With General Muscle Weakness Prior to Discharge From Recovery Room Secondary · Prior to Discharge from Recovery Room (up to 24 hours)

The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from neuromuscular blockade prior to discharge from the recovery room. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups and the overall assessments were reported as "yes" or "no" to general muscle weakness. Participants who were not cooperative with the examination were not included in the assessment.

Group	Value	95% CI
Participants 18 to 64 Years Old	0
Participants 65 to 74 Years Old	0
Participants 75 Years and Older	1

Number of Participants Who Can Perform a 5 Second Head Lift Prior to Transfer to the Recovery Room After Extubation Secondary · Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)

Participants were asked to lift their head off the table while in a supine position post-extubation and prior to transfer to recovery room. The number of participants who could perform the 5 second head lift was summarized. Participants who were not cooperative with the examination were not included in the assessment.

Group	Value	95% CI
Participants 18 to 64 Years Old	40
Participants 65 to 74 Years Old	57
Participants 75 Years and Older	31

Number of Participants Who Can Perform a 5 Second Head Lift Prior to Discharge From Recovery Room Secondary · Prior to Discharge from Recovery Room (up to 24 hours)

Participants were asked to lift their head off the table while in a supine position just prior to discharge from the recovery room. The number of participants who could perform the 5 second head lift was summarized. Participants who were not cooperative with the examination were not included in the assessment.

Group	Value	95% CI
Participants 18 to 64 Years Old	46
Participants 65 to 74 Years Old	58
Participants 75 Years and Older	38

Adverse events — posted to ClinicalTrials.gov

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

Participants 18 to 64 Years Old

Serious: 4/48 (8%)

Deaths: 0/48

Participants 65 to 74 Years Old

Serious: 8/62 (13%)

Deaths: 0/62

Participants 75 Years and Older

Serious: 3/40 (8%)

Deaths: 0/40

Serious adverse events (27 terms)

Reaction	System	Participants 18 to 64 Year…	Participants 65 to 74 Year…	Participants 75 Years and …
Anaemia	Blood and lymphatic system disorders	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—
Abdominal haematoma	Gastrointestinal disorders	—	—	—
Abdominal hernia	Gastrointestinal disorders	—	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—
Intestinal perforation	Gastrointestinal disorders	—	—	—
Mechanical ileus	Gastrointestinal disorders	—	—	—
Small intestinal perforation	Gastrointestinal disorders	—	—	—
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—
Catheter related complication	General disorders	—	—	—
Localised oedema	General disorders	—	—	—
Pyrexia	General disorders	—	—	—
Cellulitis	Infections and infestations	—	—	—
Device related infection	Infections and infestations	—	—	—
Sepsis	Infections and infestations	—	—	—
Anastomotic leak	Injury, poisoning and procedural complications	—	—	—
Overdose	Injury, poisoning and procedural complications	—	—	—
Post procedural complication	Injury, poisoning and procedural complications	—	—	—
Post procedural haemorrhage	Injury, poisoning and procedural complications	—	—	—
Postoperative ileus	Injury, poisoning and procedural complications	—	—	—
Oxygen saturation decreased	Investigations	—	—	—
Metastatic carcinoma of the bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—
Respiratory distress	Respiratory, thoracic and mediastinal disorders	—	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—

Other adverse events (29 terms — click to expand)

Reaction	System	Participants 18 to 64 Year…	Participants 65 to 74 Year…	Participants 75 Years and …
Procedural pain	Injury, poisoning and procedural complications	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Pyrexia	General disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Post procedural nausea	Injury, poisoning and procedural complications	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Hypocalcaemia	Metabolism and nutrition disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Procedural hypertension	Injury, poisoning and procedural complications	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—
Hypertension	Vascular disorders	—	—	—
Tachycardia	Cardiac disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—
Chills	General disorders	—	—	—
Oedema peripheral	General disorders	—	—	—
Incision site complication	Injury, poisoning and procedural complications	—	—	—
Anxiety	Psychiatric disorders	—	—	—
Scrotal oedema	Reproductive system and breast disorders	—	—	—
Anaemia postoperative	Injury, poisoning and procedural complications	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—
Confusional state	Psychiatric disorders	—	—	—
Insomnia	Psychiatric disorders	—	—	—
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—

Most-reported serious reactions: Anaemia, Atrial fibrillation, Abdominal haematoma, Abdominal hernia, Gastrointestinal haemorrhage, Intestinal perforation, Mechanical ileus, Small intestinal perforation.

Data from ClinicalTrials.gov NCT00474617 adverse events section.

Sponsor's own description

The purpose of the study is to compare the effectiveness, safety and pharmacokinetics of sugammadex in participants 65 and over with participants under 65. There is no hypothesis defined for the study.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.