Trial Outcomes & Findings for Low Doses of Ketamine and Postoperative Quality of Recovery (NCT NCT02571153)

Results Overview

Quality of postoperative functional recovery assessed by the questionnaire QoR40 The quality of postoperative functional recovery was assessed by the QoR-40 questionnaire, which assesses five dimensions of recovery (physical comfort - 12 items; emotional state - 7 items; physical independence - 5 items; physiological support - 7 items; and pain - 7 items). Each item was rated on a five-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR-40 ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery). The QoR-40 was administered by a blind investigator 24 hours after surgery.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

135 participants

Primary outcome timeframe

24 hours

Results posted on

2017-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Saline Group Normal saline 0.9% (5 mL) Normal saline: Intravenous normal saline 0.9% 5 mL	Ketamine 0.2 ketamine 0.2 mg/kg (5 mL) Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia	Ketamine 0.4 ketamine 0.4 mg/kg (5 mL) Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia
Overall Study STARTED	45	45	45
Overall Study COMPLETED	39	37	43
Overall Study NOT COMPLETED	6	8	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Low Doses of Ketamine and Postoperative Quality of Recovery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Saline Group n=39 Participants Normal saline 0.9% (5 mL) Normal saline: Intravenous normal saline 0.9% 5 mL	Ketamine 0.2 n=37 Participants ketamine 0.2 mg/kg (5 mL) Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia	Ketamine 0.4 n=43 Participants ketamine 0.4 mg/kg (5 mL) Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia	Total n=119 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants	37 Participants n=7 Participants	43 Participants n=5 Participants	119 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	41.8 years STANDARD_DEVIATION 11.3 • n=5 Participants	47.2 years STANDARD_DEVIATION 13.3 • n=7 Participants	44.1 years STANDARD_DEVIATION 11.4 • n=5 Participants	44.3 years STANDARD_DEVIATION 12.1 • n=4 Participants
Gender Female	31 Participants n=5 Participants	34 Participants n=7 Participants	37 Participants n=5 Participants	102 Participants n=4 Participants
Gender Male	8 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	17 Participants n=4 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: Total of 152 patients were first assessed for eligibility in this study; however, 17 were excluded because they refused participation, or met any of the exclusion criteria. Thus, 135 participants were randomly allocated to the study groups. Later, 6 participants in group S, 8 in group K2, and 2 in group K4 were excluded due to protocol deviations.

Quality of postoperative functional recovery assessed by the questionnaire QoR40 The quality of postoperative functional recovery was assessed by the QoR-40 questionnaire, which assesses five dimensions of recovery (physical comfort - 12 items; emotional state - 7 items; physical independence - 5 items; physiological support - 7 items; and pain - 7 items). Each item was rated on a five-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR-40 ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery). The QoR-40 was administered by a blind investigator 24 hours after surgery.