Trial Outcomes & Findings for Resistance Under the Microscope (NCT NCT01441843)

Results Overview

The Quality of Recovery Score - 40 (QoR-40), a 40-item scale, is used to assess the quality of recovery. Each item is rated on a five-point Likert scale (1-5), and the QoR-40 score is calculated as the sum of the scores on these items. Minimal possible score = 40, maximal possible score = 200. A higher score indicates a higher level of quality of recovery.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

400 participants

Primary outcome timeframe

Baseline; first postoperative working day; seventh postoperative day.

Results posted on

2023-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	Lorazepam Lorazepam 4mg/4ml Lorazepam : Once 1mg \<75kg body weight, 1.5mg 75kg and \>75kg body weight, IV, before surgery	NaCl 0.9% NaCl 0.9% 4ml NaCl 0.9% (Sodium Chloride) : Once 1ml \<75kg body weight, 1.5ml 75kg or \>75kg body weight, IV, before surgery
Overall Study STARTED	200	200
Overall Study COMPLETED	188	195
Overall Study NOT COMPLETED	12	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Resistance Under the Microscope

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lorazepam n=198 Participants Lorazepam 4mg/4ml Lorazepam : Once 1mg \<75kg body weight, 1.5mg 75kg and \>75kg body weight, IV, before surgery	NaCl 0.9% n=200 Participants NaCl 0.9% 4ml NaCl 0.9% (Sodium Chloride) : Once 1ml \<75kg body weight, 1.5ml 75kg or \>75kg body weight, IV, before surgery	Total n=398 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	190 Participants n=5 Participants	191 Participants n=7 Participants	381 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Age, Continuous	39.5 years STANDARD_DEVIATION 13.7 • n=5 Participants	39.3 years STANDARD_DEVIATION 13.6 • n=7 Participants	39.4 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants	85 Participants n=7 Participants	174 Participants n=5 Participants
Sex: Female, Male Male	109 Participants n=5 Participants	115 Participants n=7 Participants	224 Participants n=5 Participants
Region of Enrollment Netherlands	198 participants n=5 Participants	200 participants n=7 Participants	398 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline; first postoperative working day; seventh postoperative day.

The Quality of Recovery Score - 40 (QoR-40), a 40-item scale, is used to assess the quality of recovery. Each item is rated on a five-point Likert scale (1-5), and the QoR-40 score is calculated as the sum of the scores on these items. Minimal possible score = 40, maximal possible score = 200. A higher score indicates a higher level of quality of recovery.

Outcome measures

Outcome measures
Measure	Lorazepam n=188 Participants Lorazepam 4mg/4ml Lorazepam : Once 1mg \<75kg body weight, 1.5mg 75kg and \>75kg body weight, IV, before surgery	NaCl 0.9% n=195 Participants NaCl 0.9% 4ml NaCl 0.9% (Sodium Chloride) : Once 1ml \<75kg body weight, 1.5ml 75kg or \>75kg body weight, IV, before surgery
Quality of Recovery Score Seventh postoperative day	172.8 scores on a scale Standard Deviation 21.0	176.3 scores on a scale Standard Deviation 18.8
Quality of Recovery Score First postoperative working day	174.5 scores on a scale Standard Deviation 13.0	176.4 scores on a scale Standard Deviation 12.6
Quality of Recovery Score Baseline	177.2 scores on a scale Standard Deviation 17.4	180.4 scores on a scale Standard Deviation 17.5

SECONDARY outcome

Timeframe: baseline; after surgery but before discharge; 1 week after surgery

The State-Trait Anxiety Inventory (STAI) is used to assess anxiety. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of anxiety.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline; 1 week after surgery

The Multidimensional Fatigue Inventory (MFI) is used to assess the change in fatigue. The MFI is a self-report instrument designed to measure fatigue. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of fatigue.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline; 1 week after surgery

The State-Trait Anger Scale (STAS) is used to assess the aggression regulation. STAS is one of the most used tools for measuring aggression. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of aggression

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline; 1 week after surgery

The Hospital Anxiety and Depression Scale (HADS) is used to assess the change in depression. The HADS is a well known international outcome measurement for anxiety and depression. It is often used in the clinical setting. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of depression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; first postoperative working day; 1 week after surgery

Medical records are used to assess somatic symptoms and complaints. Next to the medical records, dimensions of the QoR-40 (physical comfort, physical independence and pain) are used to measure somatic symptoms and complaints.

Outcome measures

Outcome data not reported

Adverse Events

Lorazepam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NaCl 0.9%

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

Dr. M. Klimek

Erasmus University Medical Centre

Phone: +31107033713

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place