Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Low Doses of Ketamine and Postoperative Quality of Recovery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02571153
Recruitment Status : Completed
First Posted : October 8, 2015
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Eduardo Toshiyuki Moro, Pontificia Universidade Catolica de Sao Paulo

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Postoperative Pain
Postoperative Nausea and Vomiting
Interventions Drug: Ketamine 0.4 mg/kg
Drug: Normal saline
Drug: Ketamine 0.2 mg/kg
Enrollment 135
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Saline Group Ketamine 0.2 Ketamine 0.4
Hide Arm/Group Description

Normal saline 0.9% (5 mL)

Normal saline: Intravenous normal saline 0.9% 5 mL

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 mg/kg (5 mL)

Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia

Period Title: Overall Study
Started 45 45 45
Completed 39 37 43
Not Completed 6 8 2
Arm/Group Title Saline Group Ketamine 0.2 Ketamine 0.4 Total
Hide Arm/Group Description

Normal saline 0.9% (5 mL)

Normal saline: Intravenous normal saline 0.9% 5 mL

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 mg/kg (5 mL)

Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia

Total of all reporting groups
Overall Number of Baseline Participants 39 37 43 119
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 37 participants 43 participants 119 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
39
 100.0%
37
 100.0%
43
 100.0%
119
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 37 participants 43 participants 119 participants
41.8  (11.3) 47.2  (13.3) 44.1  (11.4) 44.3  (12.1)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 37 participants 43 participants 119 participants
Female
31
  79.5%
34
  91.9%
37
  86.0%
102
  85.7%
Male
8
  20.5%
3
   8.1%
6
  14.0%
17
  14.3%
1.Primary Outcome
Title Quality of Postoperative Recovery Assessed by QoR-40 Questionnaire 24 Hours After Surgery
Hide Description 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.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Saline Group Ketamine 0.2 Ketamine 0.4
Hide Arm/Group Description:

Normal saline 0.9% (5 mL)

Normal saline: Intravenous normal saline 0.9% 5 mL

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 mg/kg (5 mL)

Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia

Overall Number of Participants Analyzed 39 37 43
Mean (80% Confidence Interval)
Unit of Measure: units on a scale
187.8
(177.4 to 198.2)
189.6
(177.6 to 201.6)
186.8
(175.5 to 198.1)
2.Secondary Outcome
Title Length of PACU Stay
Hide Description Length of stay at postanesthesia recovery room
Time Frame During the stay at postanesthesia recovery room (about 90 to 120 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.
Arm/Group Title Saline Group Ketamine 0.2 Ketamine 0.4
Hide Arm/Group Description:

Normal saline 0.9% (5 mL)

Normal saline: Intravenous normal saline 0.9% 5 mL

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 mg/kg (5 mL)

Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia

Overall Number of Participants Analyzed 39 37 43
Mean (80% Confidence Interval)
Unit of Measure: minutes
82.9
(59.2 to 106.6)
84.5
(68 to 101)
86
(52.1 to 119.9)
3.Secondary Outcome
Title Occurrence of Postoperative, Nausea and Vomiting
Hide Description Percentage of participants with postoperative nausea and vomiting at the PACU and during the hospital ward stay
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.
Arm/Group Title Saline Group Ketamine 0.2 Ketamine 0.4
Hide Arm/Group Description:

Normal saline 0.9% (5 mL)

Normal saline: Intravenous normal saline 0.9% 5 mL

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 mg/kg (5 mL)

Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia

Overall Number of Participants Analyzed 39 37 43
Measure Type: Number
Unit of Measure: percentage of participants
30.8 29.7 39.5
4.Secondary Outcome
Title Occurrence of Pain at PACU Using a 0-10 Numeric Pain Rating Scale
Hide Description Occurrence of pain at the PACU. Average Pain will be calculated. The pain score will be evaluated using a 0-10 numeric pain rating scale, where zero mean no pain and 10 the worst imaginable pain.
Time Frame 90 minutes postanesthesia at recovery room
Hide Outcome Measure Data
Hide Analysis Population Description
Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.
Arm/Group Title Saline Group Ketamine 0.2 Ketamine 0.4
Hide Arm/Group Description:

Normal saline 0.9% (5 mL)

Normal saline: Intravenous normal saline 0.9% 5 mL

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 mg/kg (5 mL)

Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia

Overall Number of Participants Analyzed 39 37 43
Mean (80% Confidence Interval)
Unit of Measure: units on a scale
3.8
(0.2 to 7.4)
2.6
(0 to 5.8)
2.8
(0 to 5.8)
5.Secondary Outcome
Title Morphine Consumption (mg) at PACU
Hide Description Morphine consumption (mg) at PACU (about 90 to 120 minutes)
Time Frame During the stay at postanesthesia recovery room (about 90 to 120 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.
Arm/Group Title Saline Group Ketamine 0.2 Ketamine 0.4
Hide Arm/Group Description:

Normal saline 0.9% (5 mL)

Normal saline: Intravenous normal saline 0.9% 5 mL

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 mg/kg (5 mL)

Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia

Overall Number of Participants Analyzed 39 37 43
Mean (80% Confidence Interval)
Unit of Measure: mg
1.6
(0 to 3.7)
0.9
(0 to 2.4)
1.1
(0 to 2.7)
6.Secondary Outcome
Title The Severity of Postoperative Pain
Hide Description

The severity of postoperative pain was rated the higher score of pain (NRS) during the hospital ward stay.

Pain was evaluated using a 0-10 numeric pain rating scale (NRS), where zero meant no pain and 10 the worst imaginable pain.

Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.
Arm/Group Title Saline Group Ketamine 0.2 Ketamine 0.4
Hide Arm/Group Description:

Normal saline 0.9% (5 mL)

Normal saline: Intravenous normal saline 0.9% 5 mL

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 mg/kg (5 mL)

Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia

Overall Number of Participants Analyzed 39 37 43
Mean (80% Confidence Interval)
Unit of Measure: units on a scale
3.2
(0.4 to 6)
2.8
(0 to 5.5)
3.6
(0.5 to 6.5)
7.Secondary Outcome
Title Percentage of Participants With Tramadol Consumption
Hide Description Percentage of Participants with Tramadol during the ward stay
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.
Arm/Group Title Saline Group Ketamine 0.2 Ketamine 0.4
Hide Arm/Group Description:

Normal saline 0.9% (5 mL)

Normal saline: Intravenous normal saline 0.9% 5 mL

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 mg/kg (5 mL)

Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia

Overall Number of Participants Analyzed 39 37 43
Measure Type: Number
Unit of Measure: percentage of participants
5.1 10.8 13.9
Time Frame 24 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Saline Group Ketamine 0.2 Ketamine 0.4
Hide Arm/Group Description

Normal saline 0.9% (5 mL)

Normal saline: Intravenous normal saline 0.9% 5 mL

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 mg/kg (5 mL)

Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia

All-Cause Mortality
Saline Group Ketamine 0.2 Ketamine 0.4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Saline Group Ketamine 0.2 Ketamine 0.4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/37 (0.00%)   0/43 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Saline Group Ketamine 0.2 Ketamine 0.4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/37 (0.00%)   0/43 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eduardo Toshiyuki Moro
Organization: Pontificia UCSP
EMail: eduardo_moro@terra.com.br
Layout table for additonal information
Responsible Party: Eduardo Toshiyuki Moro, Pontificia Universidade Catolica de Sao Paulo
ClinicalTrials.gov Identifier: NCT02571153    
Other Study ID Numbers: PUCSP 057539/2015
First Submitted: October 2, 2015
First Posted: October 8, 2015
Results First Submitted: September 28, 2016
Results First Posted: March 6, 2017
Last Update Posted: March 6, 2017