Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery

• ClinicalTrials.gov Identifier: NCT02334059
• Recruitment Status: Completed
• First Posted: January 8, 2015
• Results First Posted: November 19, 2019
• Last Update Posted: June 1, 2020
• Sponsor: Milton S. Hershey Medical Center
• Information provided by (Responsible Party): Sanjib D Adhikary, Milton S. Hershey Medical Center

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Obesity
• Interventions: Drug: Ketamine; Drug: Ketamine plus magnesium; Other: Placebo
• Enrollment: 108

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Ketamine	Ketamine Plus Magnesium	Placebo
Arm/Group Description	Ketamine: 0.5 mg/kg IV dose Ketamine: Ketamine infusion plus placebo infusion of normal saline Placebo: 2 placebo infusions	Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV Ketamine plus magnesium: Ketamine plus magnesium infusion	Placebo (normal saline) Placebo: 2 placebo infusions
Period Title: Overall Study
Started	37	34	37
Completed	37	34	37
Not Completed	0	0	0

Baseline Characteristics

Arm/Group Title		Ketamine	Ketamine Plus Magnesium	Placebo	Total
Arm/Group Description		Ketamine: 0.5 mg/kg IV dose Ketamine: Ketamine infusion plus placebo infusion of normal saline Placebo: 2 placebo infusions	Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV Ketamine plus magnesium: Ketamine plus magnesium infusion	Placebo (normal saline) Placebo: 2 placebo infusions	Total of all reporting groups
Overall Number of Baseline Participants		37	34	37	108
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	37 participants	34 participants	37 participants	108 participants
		43.68 (10.82)	44.15 (11.91)	39.97 (11.60)	42.56 (11.49)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	37 participants	34 participants	37 participants	108 participants
	Female	27 73.0%	29 85.3%	29 78.4%	85 78.7%
	Male	10 27.0%	5 14.7%	8 21.6%	23 21.3%
Race and Ethnicity Not Collected [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants	0 participants
					0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	37 participants	34 participants	37 participants	108 participants
		37	34	37	108
BMI; Mean (Standard Deviation); Unit of measure: Kg/m2
	Number Analyzed	37 participants	34 participants	37 participants	108 participants
		47.48 (9.85)	45.57 (6.73)	47.37 (8.70)	46.84 (8.53)
Duration of Surgery; Mean (Standard Deviation); Unit of measure: Minutes
	Number Analyzed	37 participants	34 participants	37 participants	108 participants
		55.14 (8.25)	67.06 (15.12)	64.78 (13.23)	62.19 (13.39)
Pre-operative Pain Score [1]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	37 participants	34 participants	37 participants	108 participants
		0.27 (1.04)	0.35 (0.95)	0.41 (1.3)	0.34 (1.1)
		[1] Measure Description: Pain Scores will be determined pre-operatively using the Visual Analogue Scale (VAS). The VAS is a 10 point scale, where 0 = no pain and 10 = worst pain a subject has ever felt.
Pre-operative sedation score [1]; Median (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	37 participants	34 participants	37 participants	108 participants
		2 (0.0)	1.97 (0.17)	2 (0.16)	2 (0.14)
		[1] Measure Description: Sedation scoring will be determined using the Modified Ramsay Sedation Scale. The Modified Ramsay Sedation Scale is a 6 point scale used to determine alertness, where 1 = patient is awake, anxious, agitated, or restless and 6 = patient with no response to any stimuli (light, noise, or pain). A higher number represents an increased sedative state.
Pre-operative PONV score [1]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	37 participants	34 participants	37 participants	108 participants
		0.16 (0.50)	0.03 (0.17)	0.14 (0.54)	0.11 (0.44)
		[1] Measure Description: The Pre-Operative PONV score will be determined using the PONV Impact Scale. This scale consists of two questions (rated from 0 to 3) for both questions and the sum of the responses are added for a total PONV score. Question 1 asks if an individual has vomited or had any dry retching, where 0 = Not at all, 1 = Once, 2= Twice, and 3= Three or more times. Question 2 asks if an individual has experienced a feeling of nausea, where 0 = Not at all, 1 = Sometimes, 2 = Often or most of the time, and 3 = All of the time. total score (mean and std deviation) is reported and total ranges from 0-3.

Outcome Measures

1. Primary Outcome

Title	Total Hydromorphone Use
Description	Total hydromorphone use in 1st 24 hours post-operatively.
Time Frame	During surgery and 24 hours post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ketamine	Ketamine Plus Magnesium	Placebo
Arm/Group Description:	Ketamine: 0.5 mg/kg IV dose Ketamine: Ketamine infusion plus placebo infusion of normal saline Placebo: 2 placebo infusions	Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV Ketamine plus magnesium: Ketamine plus magnesium infusion	Placebo (normal saline) Placebo: 2 placebo infusions
Overall Number of Participants Analyzed	37	34	37
Mean (95% Confidence Interval); Unit of Measure: mcg/Kg
Intraoperative	161.5; (119.6 to 203.3)	159.6; (109.4 to 209.7)	195.9; (149.6 to 242.3)
PACU	41.9; (20.5 to 63.3)	47.8; (24.6 to 71.0)	47.3; (24.1 to 70.5)

2. Secondary Outcome

Title	Pain Scores Using Verbal Analogue Scale (VAS)
Description	Pain scores using VAS scale will be recorded pre-operatively, in the PACU, and every 4 hours until 24 hours post-op. The VAS is a 10 point scale, where 0 = no pain and 10 = the worst pain a subject has ever felt. The highest value 10, indicates an extreme self reported level of pain.
Time Frame	Preoperatively and the 1st 24 hours post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ketamine	Ketamine Plus Magnesium	Placebo
Arm/Group Description:	Ketamine: 0.5 mg/kg IV dose Ketamine: Ketamine infusion plus placebo infusion of normal saline Placebo: 2 placebo infusions	Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV Ketamine plus magnesium: Ketamine plus magnesium infusion	Placebo (normal saline) Placebo: 2 placebo infusions
Overall Number of Participants Analyzed	37	34	37
Mean (95% Confidence Interval); Unit of Measure: units on a scale
Prior to Surgery	0.41; (-0.03 to 0.84)	0.35; (0.02 to 0.68)	0.27; (-0.08 to 0.62)
PACU	5.78; (4.86 to 6.71)	6.03; (4.86 to 6.78)	5.95; (4.91 to 6.98)
4h after surgery	3.89; (3.20 to 4.57)	4.29; (3.53 to 5.06)	4.65; (4.01 to 5.29)
8h after surgery	3.67; (3.09 to 4.24)	3.75; (2.9 to 4.60)	3.64; (3.08 to 4.20)
12h after surgery	3.16; (2.59 to 3.73)	3.91; (3.28 to 4.53)	2.69; (2.07 to 3.30)
16h after surgery	2.97; (2.3 to 3.64)	3.64; (2.89 to 4.38)	3.09; (2.51 to 3.66)
20h after surgery	3.22; (2.42 to 4.01)	4.13; (3.45 to 4.8)	2.94; (2.36 to 3.53)
24h after surgery	3.24; (2.59 to 3.88)	3.48; (2.81 to 4.15)	3.33; (2.63 to 4.04)

3. Secondary Outcome

Title	Intraoperative Minimum Alveolar Concentration (MAC) of Desflurane
Description	The average MAC concentration of desflurane will be recorded during the intraoperative period. The Minimum Alveolar Concentration (MAC) of an inhaled anesthetic is the alveolar (or end-expiratory) concentration at which 50% of patients will not show a motor response to a standardized surgical incision.
Time Frame	Intraoperative period

Outcome Measure Data

Analysis Population Description

Intraoperative period: Intraoperative Minimum Alveolar Concentration (MAC) of desflurane

Arm/Group Title	Ketamine	Ketamine Plus Magnesium	Placebo
Arm/Group Description:	Ketamine: 0.5 mg/kg IV dose Ketamine: Ketamine infusion plus placebo infusion of normal saline Placebo: 2 placebo infusions	Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV Ketamine plus magnesium: Ketamine plus magnesium infusion	Placebo (normal saline) Placebo: 2 placebo infusions
Overall Number of Participants Analyzed	37	34	37
Mean (95% Confidence Interval); Unit of Measure: Minimal Alveolar Concentration (MAC)
	4.05; (3.74 to 4.35)	4.02; (3.73 to 4.32)	4.34; (3.98 to 4.71)

Adverse Events

Time Frame	Perioperative time period (within 24 hours) up to 24 hours post surgery
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Ketamine	Ketamine Plus Magnesium	Placebo
Arm/Group Description	Ketamine: 0.5 mg/kg IV dose Ketamine: Ketamine infusion plus placebo infusion of normal saline Placebo: 2 placebo infusions	Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV Ketamine plus magnesium: Ketamine plus magnesium infusion	Placebo (normal saline) Placebo: 2 placebo infusions
All-Cause Mortality
	Ketamine	Ketamine Plus Magnesium	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/37 (0.00%)	0/34 (0.00%)	0/37 (0.00%)
Serious Adverse Events
	Ketamine	Ketamine Plus Magnesium	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/37 (0.00%)	0/34 (0.00%)	0/37 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Ketamine	Ketamine Plus Magnesium	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/37 (0.00%)	0/34 (0.00%)	0/37 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Sanjib D Adhikary
• Organization: Penn State Health Anesthesiology and Perioperative Medicine
• Phone: 717-531-6597
• EMail: sadhikary1@pennstatehealth.psu.edu

• Responsible Party: Sanjib D Adhikary, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT02334059
• Other Study ID Numbers: STUDY00001623
• First Submitted: December 23, 2014
• First Posted: January 8, 2015
• Results First Submitted: July 15, 2019
• Results First Posted: November 19, 2019
• Last Update Posted: June 1, 2020