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Futility
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This study is being done to determine if combined infusions of lidocaine and ketamine is better than a lidocaine or ketamine infusion alone, or to placebo in improving recovery after abdominal hysterectomy. Participants will be randomized into one of four groups. Evaluations will be done through walking tests, pain and fatigue questionnaires and blood tests.
Subjects undergoing abdominal hysterectomy surgery are randomized into one of four groups: Intravenous Lidocaine, Intravenous Ketamine, Intravenous Lidocaine and Ketamine or Placebo. Subjects will perform a six-minute walk test prior to surgery and on the second day postoperatively. After surgery and on days 1 and 2 after surgery, subjects will rate their pain. On day 1 postoperatively, subjects will rate their fatigue. On postoperative days 1 and 2 incisional pain will be analysed using von Frey filaments. Two hours after surgery, 10 ml of venous blood will be sampled for cytokine analysis. Telephone follow up will take place 6 and 12 months postoperatively to access pain and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Active Comparator | Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery |
|
| Placebo | Placebo Comparator | A lidocaine placebo is administered intravenously throughout surgery and during the 24 hours after surgery. |
|
| Ketamine | Active Comparator | Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery |
|
| ketamine + Lidocaine | Active Comparator | both ketamine and Lidocaine are administered intravenously throughout surgery and during the 24 hours after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two | The effects of lidocaine and ketamine on functional recovery assessed by 6 minute walk test on postoperative day two after hysterectomy. This outcome measures return to ambulation after surgery. | postoperative day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2 | Verbal response pain scores (VRS) at PACU admission and discharge as well as mornings and afternoons of postoperative days 1 and 2. VRS scale ranges from 0 to 10, with 0 denoting no pain and 10 denoting worst possible pain. | PACU admission and discharge, postoperative mornings and afternoons on days 1 and 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Grady, MD | The Cleveland Clinic | Principal Investigator |
| Daniel I Sessler, MD | The Cleveland Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic/Hillcrest Hospital | Mayfield Heights | Ohio | 44124 | United States |
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This is a factorial study design with 64 patients randomized to 2 treatments each: lidocaine or placebo and ketamine or placebo. Each treatment was analyzed separately (i.e., lidocaine versus placebo and ketamine versus placebo separately). Though there are 4 distinct groups, the same 64 patients are in both lidocaine and ketamine analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lidocaine/Ketamine | Intravenous Lidocaine + Ketamine Group Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours. Ketamine was given as a bolus (0.35 mg/kg), followed by ketamine infusion of 0.2 mg/kg/h for the first 2 hours, and then 0.12 mg/kg/h for 24 postoperative hours. Medication doses were based on actual patient body weight to a maximum of 150% of ideal body weight based on the formula: 49 kg + 0.6 kg for each centimeter of height exceeding 152 centimeters |
| FG001 | Lidocaine | Intravenous lidocaine Group - Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours. |
| FG002 | Ketamine | Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively. |
| FG003 | Placebo | A placebo is administered intravenously throughout surgery and during the 24 hours after surgery. A placebo infusion will be substituted for the ketamine or lidocaine not given |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lidocaine/Ketamine | Intravenous Lidocaine and Ketamine Group - Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours. Ketamine was given as a bolus (0.35 mg/kg), followed by ketamine infusion of 0.2 mg/kg/h for the first 2 hours, and then 0.12 mg/kg/h for 24 postoperative hours. Medication doses were based on actual patient body weight to a maximum of 150% of ideal body weight based on the formula: 49 kg + 0.6 kg for each centimeter of height exceeding 152 centimeters. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two | The effects of lidocaine and ketamine on functional recovery assessed by 6 minute walk test on postoperative day two after hysterectomy. This outcome measures return to ambulation after surgery. | Posted | Mean | Standard Deviation | meters | postoperative day 2 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lidocaine | Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery Lidocaine: Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Sessler, MD | Cleveland Clinic | 216-444-4200 | sesslerd@ccf.org |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Placebo | Drug | Placebo boluses and infusions will be substituted |
|
| Ketamine | Drug | Ketamine (0.25 mg/kg) will be given followed by an infusion of ketamine (0.25 mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively. |
|
| Ketamine + Lidocaine | Drug | both Ketamine and Lidocaine will be given |
|
| Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2 | intraoperative through postoperative day 2 |
| Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day | 2 hours after surgery, on postoperative day 1 |
| Verbal Response Fatigue Score on Postoperative Day 1 | Verbal response fatigue score on postoperative day 1. Verbal response fatigue score measured on a scale ranging from 0 to 10, where 0 is no fatigue and 10 is the worst possible fatigue. | postoperative day 1 |
| vertical incision |
|
| BG001 | Lidocaine | Intravenous lidocaine Group - A lidocaine is administered intravenously through out surgery and 24 hours after surgery. Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours. |
| BG002 | Ketamine | Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively. |
| BG003 | Placebo | A placebo is administered intravenously throughout surgery and during the 24 hours after surgery. A placebo infusion will be substituted for the ketamine or Lidocaine not given |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| American Society of Anesthesiologists Physical Status | American Society of Anesthesiologists Physical Status applied to each patient ranging from I to VI. The scale is defined as follows: I: A normal healthy patient II: A patient with mild systemic disease III: A patient with severe systemic disease IV: A patient with severe systemic disease that is a constant threat to life V: A moribund patient who is not expected to survive without the operation VI: A declared brain-dead patient whose organs are being removed for donor purposes | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg per meters squared |
|
| Preoperative 6-MWD | Mean | Standard Deviation | m |
|
| Nonlidocaine |
Intravenous Nonlidocaine Group - A lidocaine placebo is administered intravenously through out surgery and 24 hours after surgery. Placebo boluses and infusions will be substituted for the lidocaine |
| OG002 | Ketamine | Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively. |
| OG003 | Nonketamine | A ketamine placebo is administered intravenously throughout surgery and during the 24 hours after surgery. A placebo infusion will be substituted for the ketamine not given |
|
|
|
| Secondary | Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2 | Verbal response pain scores (VRS) at PACU admission and discharge as well as mornings and afternoons of postoperative days 1 and 2. VRS scale ranges from 0 to 10, with 0 denoting no pain and 10 denoting worst possible pain. | Posted | Mean | Standard Deviation | units on a scale | PACU admission and discharge, postoperative mornings and afternoons on days 1 and 2 |
|
|
|
|
| Secondary | Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2 | Posted | Median | Inter-Quartile Range | milligram morphine sulfate equivalents | intraoperative through postoperative day 2 |
|
|
|
|
| Secondary | Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day | Posted | Number | percentage of participants | 2 hours after surgery, on postoperative day 1 |
|
|
|
|
| Secondary | Verbal Response Fatigue Score on Postoperative Day 1 | Verbal response fatigue score on postoperative day 1. Verbal response fatigue score measured on a scale ranging from 0 to 10, where 0 is no fatigue and 10 is the worst possible fatigue. | 11 patients had missing POD 1 fatigue scores (e.g., 11 for lidocaine vs. nonlidocaine and 11 for ketamine vs. nonketamine). | Posted | Mean | Standard Deviation | units on a scale | postoperative day 1 |
|
|
|
|
| 16 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Placebo | placebo is administered intravenously through out surgery and 24 hours after surgery. | 16 | 16 | 0 | 16 | 0 | 16 |
| EG002 | Ketamine | Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively. | 15 | 15 | 0 | 15 | 0 | 15 |
| EG003 | Ketamine + Lidocaine | both ketamine and Lidocaine administered intravenously throughout surgery and during the 24 hours after surgery. | 15 | 15 | 0 | 15 | 0 | 15 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| Aniline Compounds |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| PACU discharge |
|
| POD 1 |
|
| POD 2 |
|
Ketamine compared to placebo at PACU admit using a t test |
| t-test, 2 sided |
| 0.54 |
97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial. |
| Mean Difference (Final Values) |
| -0.5 |
| 2-Sided |
| 97.5 |
| -2.8 |
| 1.9 |
| Superiority or Other |
| Lidocaine versus nonlidocaine on pain severity at postoperative care unit discharge was assessed using a t test. | t-test, 2 sided | 0.11 | 97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial. | Mean Difference (Final Values) | -0.9 | 2-Sided | 97.5 | -2.5 | 0.8 | Superiority or Other |
| Ketamine versus nonketamine on postoperative care unit discharge pain severity was assessed using a t test. | t-test, 2 sided | 0.56 | 97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial. | Mean Difference (Final Values) | 0.3 | 2-Sided | 97.5 | -1.4 | 2.0 | Superiority or Other |
| Lidocaine versus nonlidocaine on postoperative day 1 pain severity assessed using a t test. | t-test, 2 sided | 0.20 | 97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial. | Median Difference (Final Values) | 0.6 | 2-Sided | 97.5 | -0.9 | 2.2 | Superiority or Other |
| Ketamine versus nonketamine on postoperative day 1 pain severity was assessed using a t test. | t-test, 2 sided | 0.79 | 97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial. | Mean Difference (Final Values) | 0.1 | 2-Sided | 97.5 | -1.4 | 1.7 | Superiority or Other |
| Lidocaine versus nonlidocaine on postoperative day 2 pain severity was assessed using a t test. | t-test, 2 sided | 0.55 | 97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial. | Mean Difference (Final Values) | 0.3 | 2-Sided | 97.5 | -1.1 | 1.7 | Superiority or Other |
| Ketamine versus nonketamine on postoperative day 2 pain severity was assessed using a t test. | t-test, 2 sided | 0.47 | 97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial. | Mean Difference (Final Values) | 0.3 | 2-Sided | 97.5 | -1.1 | 1.8 | Superiority or Other |
| postoperative care unit |
|
| postoperative day 1 |
|
| postoperative day 2 |
|
|
Ketamine versus nonketamine on intraoperative opioid consumption was assessed using a Wilcoxon rank sum test. |
| Wilcoxon (Mann-Whitney) |
| 0.27 |
97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial. |
| Median Difference (Final Values) |
| -2 |
| 2-Sided |
| 97.5 |
| -10 |
| 5 |
| Superiority or Other |
| Lidocaine versus nonlidocaine on postoperative care unit opioid consumption was assessed using a Wilcoxon rank sum test. | Wilcoxon (Mann-Whitney) | 0.28 | 97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial. | Median Difference (Final Values) | -3 | 2-Sided | 97.5 | -15 | 5 | Superiority or Other |
| Ketamine versus nonketamine on postoperative care unit opioid consumption was assessed using a Wilcoxon rank sum test. | Wilcoxon (Mann-Whitney) | 0.22 | 97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial. | Median Difference (Final Values) | -4 | 2-Sided | 97.5 | -15 | 4 | Superiority or Other |
| Lidocaine versus nonlidocaine on postoperative day 1 opioid consumption was assessed using a Wilcoxon rank sum test. | Wilcoxon (Mann-Whitney) | 0.76 | 97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial. | Median Difference (Final Values) | 2.5 | 2-Sided | 97.5 | -13 | 21 | Superiority or Other |
| Ketamine versus nonketamine on postoperative day 1 opioid consumption was assessed using a Wilcoxon rank sum test. | Wilcoxon (Mann-Whitney) | 0.66 | 97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial. | Median Difference (Final Values) | -3 | 2-Sided | 97.5 | -19 | 14 | Superiority or Other |
| Lidocaine versus nonlidocaine on postoperative day 2 opioid consumption was assessed using a Wilcoxon rank sum test. | Wilcoxon (Mann-Whitney) | 0.30 | 97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial. | Median Difference (Final Values) | 2.5 | 2-Sided | 97.5 | -5 | 10 | Superiority or Other |
| Ketamine versus nonketamine on postoperative day 2 opioid consumption was assessed using a Wilcoxon rank sum test. | Wilcoxon (Mann-Whitney) | 0.79 | 97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial. | Median Difference (Final Values) | 0 | 2-Sided | 97.5 | -5 | 8 | Superiority or Other |
| Nausea, POD 1 |
|
| Vomiting, PACU |
|
| Vomiting, POD 1 |
|
| Ketamine versus nonketamine on PACU (postoperative care unit) nausea assessed using Pearson chi square test. | Chi-squared | 0.87 | 97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial. | Risk Ratio (RR) | 0.02 | 2-Sided | 97.5 | -0.32 | 0.36 | Numinator: ketamine; denominator: nonketamine | Superiority or Other |
| Lidocaine versus nonlidocaine on POD 1 (first postoperative day) nausea assessed using Pearson chi square test. | Chi-squared | 0.61 | 97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial. | Risk Ratio (RR) | 0.06 | 2-Sided | 97.5 | -0.31 | 0.44 | Superiority or Other |
| Ketamine versus nonketamine on POD 1(first postoperative day) nausea assessed using Pearson chi square test. | Chi-squared | 0.79 | 97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial. | Risk Ratio (RR) | 0.03 | 2-Sided | 97.5 | -0.34 | 0.41 | Superiority or Other |
| Lidocaine versus nonlidocaine on PACU (postoperative care unit) vomiting assessed using Pearson chi square test. | Chi-squared | 0.26 | 97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial. | Risk Ratio (RR) | -0.13 | 2-Sided | 97.5 | -0.38 | 0.12 | Superiority or Other |
| Ketamine versus nonketamine on PACU (postoperative care unit) vomiting assessed using a Pearson chi square test. | Chi-squared | 0.71 | 97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial. | Risk Ratio (RR) | -0.06 | 2-Sided | 97.5 | -0.31 | 0.19 | Superiority or Other |
| Lidocaine versus nonlidocaine on postoperative day 1 vomiting assessed using a Pearson chi square test. | Chi-squared | 0.52 | 97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial. | Risk Ratio (RR) | 0.06 | 2-Sided | 97.5 | -0.23 | 0.36 | Superiority or Other |
| Ketamine versus nonketamine on postoperative day 1 vomiting assessed using Pearson chi square test. | Chi-squared | 0.44 | Risk Ratio (RR) | 0.07 | 2-Sided | 97.5 | -0.22 | 0.38 | Superiority or Other |
Ketamine was compared to nonketamine on mean VRS fatigue score using a t test. |
| t-test, 2 sided |
| 0.59 |
97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial. |
| Mean Difference (Final Values) |
| 0.3 |
| 2-Sided |
| 97.5 |
| -1.80 |
| 2.57 |
| Superiority or Other |